ClinicalTrials.gg
Not yet recruitingNCT07901049Updated Oct 30, 2026

Hugo™ RAS Urology Post-Market Clinical Study

An observational study in Prostatectomy, Cystectomy and Nephrectomy, sponsored by Medtronic - MITG. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Medtronic - MITG (part of Medtronic) · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
22 Years and older
Sex
All
01

Study summary

The purpose of this study is to collect evidence on the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

02

Conditions studied

  • Prostatectomy
  • Cystectomy
  • Nephrectomy
  • Urologic Cancer

Browse trials for

03

In context

Urologic Neoplasms

155 studies on the registry are indexed under Urologic Neoplasms; 40 are open to participants now.

This study's planned enrollment of 110 is below the median of 174 across 33 observational studies indexed under Urologic Neoplasms.

Browse Urologic 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.

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
Sampling method
Non-probability sample

Study population

The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical). Subject conditions and/or diagnoses may include but are not limited to: prostate cancer, pelvic tumors, interstitial cystitis, congenital abnormalities, end-stage kidney disease (kidney failure), renal tumor, and kidney injury.

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

  • Subject is an acceptable candidate for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
  • Adult subjects (age ≥ 22 years) as required by local law
  • Subject has been indicated for a radical prostatectomy, radical cystectomy, and/or partial/radical nephrectomy
  • Subject is an acceptable candidate for any surgical approach: fully RAS procedure, laparoscopic surgical procedure, or open surgical procedure
  • The subject is willing to participate and consents to participate, as documented by a signed and dated form in accordance with the Declaration of Helsinki

Exclusion criteria

Exclusion Criteria:

  • for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
  • Subject is less than legal age of consent, legally incompetent, or otherwise considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
  • Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
  • Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
Terms in these criteria, in plain language(2)

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No

Interventions

  • DeviceRobotic Assisted Urologic Surgery

    The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical) procedures

06

What researchers measure

Primary outcomes

  1. Surgical Success Rate

    Surgical success rate, defined as a Hugo™ RAS procedure free from conversion. A qualifying conversion is an unanticipated switch from a robotic-assisted approach using the Hugo™ RAS System to the use of an alternative robotic-assisted device, laparoscopy, or open surgery.

    Time frame: Intraoperative

Secondary outcomes

  1. Rate of Complications

    Rate of subjects with complications meeting Clavien-Dindo Grade ≥ III from first incision through 30 days postprocedure

    Time frame: Enrollment through 30 days follow-up

  2. Operative Time

    Skin-to-skin operative time

    Time frame: Intraoperative

  3. Hospital Length of Stay

    Total time of hospitalization

    Time frame: Postoperatively through 30 days follow-up

  4. Mortality

    30 Day Mortality Rate

    Time frame: Enrollment through 30 day follow-up

07

Study locations

No study locations are listed for this record.

08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2027; primary completion for Apr 2028, 14 months later.

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

Registered
Oct 22, 2026
First posted
Oct 28, 2026
StartEst.
Feb 23, 2027
Primary completionEst.
Apr 30, 2028
CompletionEst.
Jul 31, 2028
Last update
Oct 30, 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.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 2 updates
  1. Oct 30, 2026
    Minor edits only
    + 1 other change: criteria formatting
  2. Oct 28, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07901049
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Feb 23, 2027 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Oct 30, 2026

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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