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Active, not recruitingNCT05696444Updated Nov 3, 2026Results posted

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

An interventional study of RAS Prostatectomy and RAS Cystectomy in Bladder Cancer, Prostate Cancer and Kidney Cancer, sponsored by Medtronic - MITG. Active, not recruiting at 6 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Medtronic - MITG (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Read the detailed description

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

02

Conditions studied

  • Bladder Cancer
  • Prostate Cancer
  • Kidney Cancer
  • Pelvic Tumor
  • Interstitial Cystitis
  • Congenital Abnormalities
  • End Stage Renal Disease
  • Renal Tumor
  • Kidney Injury
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's enrollment of 144 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 179 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse Medtronic - MITG studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult subjects (age ≥ 22 years) as required by local law
  2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
  3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
  4. The subject is willing to participate and consents to participate, as documented by a signed and dated form

Exclusion criteria

Exclusion Criteria:

  1. Subjects for which minimally invasive surgery is as determined by the Investigator
  2. Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
  3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
  4. Non-oncology subjects with an estimated of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
  5. Female subjects pregnant at the time of the surgical procedure.
  6. Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
  7. Subjects who have participated in an drug or device research study within 30 days of enrollment that would interfere with this study
  8. Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Other
    Robotic Assisted Surgery (RAS) Urologic Surgery

    Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).

    Device: RAS Prostatectomy · Device: RAS Cystectomy · Device: RAS Nephrectomy

Interventions

  • DeviceRAS Prostatectomy

    Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.

  • DeviceRAS Cystectomy

    Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.

  • DeviceRAS Nephrectomy

    Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

06

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion

    The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.

    Time frame: During surgical procedure

  2. Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.

    Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient

    Time frame: 30 days

Secondary outcomes

  1. Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.

    Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.

    Time frame: 30 days

  2. Secondary Endpoint - Operative Time (Min)

    Operative time shall be collected through the length of the procedure.

    Time frame: up to 720 minutes

  3. Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).

    Intraoperative estimated blood loss shall be collected through the length of the procedure.

    Time frame: intraoperative

  4. Secondary Endpoint - Transfusion Rate Through 30 Days.

    Transfusion rate shall be collected through 30 days post-procedure

    Time frame: 30 days

  5. Secondary Endpoint - Rate of Device-related Conversions

    Rate of device-related conversions shall be collected through the length of the procedure.

    Time frame: intraoperative

  6. Secondary Endpoint - Hospital Length of Stay (Days)

    Hospital length of stay (days) shall be collected through 30 days post-procedure.

    Time frame: 30 days

  7. Secondary Endpoint - Readmission Rate (Through 30 Days)

    Readmission rate shall be collected though 30 days post-procedure.

    Time frame: 30 days

  8. Secondary Endpoint - Reoperation Rate (Through 30 Days).

    Reoperation rate shall be collected through 30 days post-procedure.

    Time frame: 30 days

  9. Secondary Endpoint - Mortality Rate (Through 30 Days).

    Mortality rate shall be collected through 30 days post-procedure.

    Time frame: 30 days

  10. Secondary Endpoint - Progression-free Survival

    Progression-free survival rate will be assessed through 5 years in oncologic subjects.

    Time frame: 5 years

  11. Secondary Endpoint - Disease-free Survival

    Disease-free survival rate will be assessed through 5 years in oncologic subjects.

    Time frame: 5 years

  12. Secondary Endpoint - Overall Survival

    Overall survival rate will be assessed through 5 years in oncologic subjects.

    Time frame: 5 years

07

Results

Posted Nov 25, 2025

Participant flow

There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 30% of the total study population. 137 subjects from 6 US sites contributed to the study cohort.

Treatment
Participant flow — Treatment
MilestoneRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Started552953
Completed552853
Not completed010
Withdrew: Physician decision010
30 Days
Participant flow — 30 Days
MilestoneRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Started552853
Completed532652
Not completed221
Withdrew: Death110
Withdrew: Missed visit111

Outcome measures

PrimaryPrimary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion

The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.

Time frame:
During surgical procedure
Reported as:
Count of participants · Participants
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion134
Statistical analysis
  • Robotic Assisted Surgery (RAS) Urologic Surgery · Exact test · p = <0.0001
PrimaryPrimary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.

Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient

Time frame:
30 days
Reported as:
Count of participants · Participants
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.251
Statistical analysis
  • Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy · Exact test · p = 0.0006 (Holm adjusted at alpha = 0.025)
  • Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy · Exact test · p = 0.0025 (Holm adjusted at alpha = 0.025)
  • Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy · Exact test · p = 0.0001 (Holm adjusted at alpha = 0.025)
SecondarySecondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.

Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.

Time frame:
30 days
Reported as:
Count of participants · Participants
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
ParticipantsFull Analysis Set (FAS) With Available DataRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.312424
SecondarySecondary Endpoint - Operative Time (Min)

Operative time shall be collected through the length of the procedure.

Time frame:
up to 720 minutes
Reported as:
Mean · Minutes
Secondary Endpoint - Operative Time (Min)
MinutesRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Operative Time (Min)227.8 ± 54.01357.8 ± 83.26178.7 ± 69.52
SecondarySecondary Endpoint - Intraoperative Estimated Blood Loss (mL).

Intraoperative estimated blood loss shall be collected through the length of the procedure.

Time frame:
intraoperative
Reported as:
Mean · mL
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
mLRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).161.5 ± 89.34394.7 ± 380.29117.5 ± 122.45
SecondarySecondary Endpoint - Transfusion Rate Through 30 Days.

Transfusion rate shall be collected through 30 days post-procedure

Time frame:
30 days
Reported as:
Count of participants · Participants
Secondary Endpoint - Transfusion Rate Through 30 Days.
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Transfusion Rate Through 30 Days.091
SecondarySecondary Endpoint - Rate of Device-related Conversions

Rate of device-related conversions shall be collected through the length of the procedure.

Time frame:
intraoperative
Reported as:
Count of participants · Participants
Secondary Endpoint - Rate of Device-related Conversions
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Rate of Device-related Conversions001
SecondarySecondary Endpoint - Hospital Length of Stay (Days)

Hospital length of stay (days) shall be collected through 30 days post-procedure.

Time frame:
30 days
Reported as:
Mean · Days
Secondary Endpoint - Hospital Length of Stay (Days)
DaysRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Hospital Length of Stay (Days)1.2 ± 0.98.4 ± 11.441.7 ± 1.53
SecondarySecondary Endpoint - Readmission Rate (Through 30 Days)

Readmission rate shall be collected though 30 days post-procedure.

Time frame:
30 days
Reported as:
Count of participants · Participants
Secondary Endpoint - Readmission Rate (Through 30 Days)
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Readmission Rate (Through 30 Days)264
SecondarySecondary Endpoint - Reoperation Rate (Through 30 Days).

Reoperation rate shall be collected through 30 days post-procedure.

Time frame:
30 days
Reported as:
Count of participants · Participants
Secondary Endpoint - Reoperation Rate (Through 30 Days).
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Reoperation Rate (Through 30 Days).031
SecondarySecondary Endpoint - Mortality Rate (Through 30 Days).

Mortality rate shall be collected through 30 days post-procedure.

Time frame:
30 days
Reported as:
Count of participants · Participants
Secondary Endpoint - Mortality Rate (Through 30 Days).
ParticipantsRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Secondary Endpoint - Mortality Rate (Through 30 Days).110
SecondarySecondary Endpoint - Progression-free Survival

Progression-free survival rate will be assessed through 5 years in oncologic subjects.

Time frame:
5 years

Results for this outcome have not been posted.

SecondarySecondary Endpoint - Disease-free Survival

Disease-free survival rate will be assessed through 5 years in oncologic subjects.

Time frame:
5 years

Results for this outcome have not been posted.

SecondarySecondary Endpoint - Overall Survival

Overall survival rate will be assessed through 5 years in oncologic subjects.

Time frame:
5 years

Results for this outcome have not been posted.

Adverse events

Collected over All Adverse Events were collected from the time of consent through 30 days post procedure.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy1/55 (1.8%)5/55 (9.1%)19/55 (34.5%)
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy1/29 (3.4%)15/29 (51.7%)7/29 (24.1%)
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy0/53 (0%)7/53 (13.2%)6/53 (11.3%)
Most frequent serious events
Showing 10 of 44
Most frequent serious events
EventRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
AnaemiaBlood and lymphatic system disorders0/557/291/53
Acute Kidney InjuryRenal and urinary disorders0/554/291/53
TachycardiaCardiac disorders0/552/290/53
Urinary Tract InfectionInfections and infestations1/552/290/53
UrosepsisInfections and infestations0/552/290/53
Procedural HaemorrhageInjury, poisoning and procedural complications0/552/290/53
Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders0/552/290/53
Cardiac ArrestCardiac disorders0/551/290/53
Abdominal HerniaGastrointestinal disorders0/551/290/53
IleusGastrointestinal disorders0/551/290/53
Most frequent other events
Most frequent other events
EventRobotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Urinary IncontinenceRenal and urinary disorders16/551/290/53
Erectile DysfunctionReproductive system and breast disorders6/550/260/33
ConstipationGastrointestinal disorders1/553/291/53
Abdominal PainGastrointestinal disorders3/552/294/53
Back PainMusculoskeletal and connective tissue disorders2/552/291/53

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
<=18 years0000
Between 18 and 65 years3393072
>=65 years22202365
Age, Continuous
Age, Continuous(Years)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
Mean62.9 ± 6.7068.9 ± 9.2461.2 ± 10.3263.5 ± 9.19
Sex: Female, Male
Sex: Female, Male(Participants)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
Female032023
Male552633114
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
Hispanic or Latino4228
Not Hispanic or Latino44193699
Unknown or Not Reported781530
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
Race, Ethnicity — White42203193
Race, Ethnicity — Black or African American741425
Race, Ethnicity — Asian1258
Race, Ethnicity — American Indian or Alaska Native0011
Race, Ethnicity — Other2103
Race, Ethnicity — Unknown3216
Race, Ethnicity — Not Reported0011
Race, Ethnicity — Native American or Other Pacific Islander0000
Region of Enrollment
Region of Enrollment(Participants)Robotic Assisted Surgery (RAS) Urologic Surgery - ProstatectomyRobotic Assisted Surgery (RAS) Urologic Surgery - CystectomyRobotic Assisted Surgery (RAS) Urologic Surgery - NephrectomyTotal
United States552953137
08

Study locations

6 sites
09

References and documents

Publications

  • Abern MR, Wiklund P, Goh AC, Kaouk JH, Crivellaro S, Lau CS, Zhumkhawala AA, Huang R, Mehrazin R, Sfakianos JP, Madueke I, Inman BA, Blaser C, Masters M, Porter JR. The first United States prospective trial using the Hugo robot-assisted surgery system. BJU Int. 2026 Jul;138(1):85-91. doi: 10.1111/bju.70314. Epub 2026 May 14. PubMed 42132526 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Oct 2024, 21 months.

Results were first posted in Nov 2025, 1 year 1 month after primary completion.

Of 244 interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 69. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2022
First posted
Jan 25, 2023
StartActual
Dec 14, 2022
Primary completionActual
Oct 10, 2024
CompletionEst.
Jan 31, 2030
Results first posted
Nov 25, 2025
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05696444
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Jan 25, 2023
Start date
Dec 14, 2022
Primary completion
Oct 10, 2024
Completion
Jan 31, 2030 (estimated)
Results posted
Nov 25, 2025
Last update
Nov 3, 2026

Study contacts

Michael Abern, MD
study chair · Duke Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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