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TerminatedNCT04771182STONESUpdated Apr 3, 2026Results posted

Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease

An interventional study of Enhanced Lithotripsy System in Urinary Stone, sponsored by Avvio Medical. Terminated at 4 sites in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Avvio Medical · Not applicable, Interventional, and Device feasibility

Why this study was terminated
Adequate enrollment has been achieved
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeally induced lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

Read the detailed description

This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeally induced lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 90 days after the last treatment session.

02

Conditions studied

  • Urinary Stone

Keywords

  • lithotripsy
  • urinary stone
  • urolithiasis
03

In context

Urinary Calculi

94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.

This study's enrollment of 25 is below the median of 120 across 61 interventional studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

Avvio Medical is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
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. Male or female aged ≥ 18 years
  2. Provides written
  3. Understands and accepts the study requirements

  4. One urinary stone eligible for treatment (minimum) that is:

    1. apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
    2. located within the renal pelvis or ureter
    3. is ≥ 3 mm in at least one dimension and ≤ 10 mm in maximum
    4. less than or equal to 10mm in maximum dimension and has an area less than 56mm2 as estimated by pre-procedure CT dimension as estimated by pre- procedure CT

  5. Participants with two or more stones in one or both kidneys are admissible and must meet the following inclusion criteria:

    1. Number of stones (≥ 3 mm) present on treated side is 2 or less
    2. Untreated stones must not be anticipated to require treatment within 30 days of enrollment, as determined by the investigator

Exclusion criteria

Exclusion Criteria:

  1. Age less than 18 years of age or over 75 years of age
  2. Diagnosis of radiolucent stones
  3. History of cystinuria
  4. Urine pH below 5.5
  5. Current untreated urinary tract infection
  6. Pregnancy
  7. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
  8. Enrollment in another research study or previous participation within 30 days of enrollment.
  9. Participant has planned general anesthesia during index procedure with (ASA) physical classification level of 3 or greater
  10. Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics
  11. Coagulation abnormality or taking prescription anticoagulants that cannot be stopped during treatment. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician
  12. Mobility issues - unable to comfortably lie still for up to 120 minutes or unable to roll from back to side
  13. Known to conductivity gel
  14. (BMI) ≥ 35 unless anticipated skin to stone distance (anticipated distance from site of ELS treatment head to stone per pre-operative CT) is \<135mm
  15. Implanted spinal cord neurostimulator intrathecal pump or any device that may interfere with energy transmission
  16. Participant has open wounds, lesions, dermatitis, or ischemic tissues in the treatment area
  17. Participant has had a major surgery that removed tissue around the spinal cord (e.g. a laminectomy) within the treatment area
  18. Participant will undergo treatment of a stone located in the distal ureter and has previous hernia repair or surgical mesh implanted in the inguinal/hypogastric regions
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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Enhanced Lithotripsy System

    Treatment of urinary stone disease with the Enhanced Lithotripsy System

    Device: Enhanced Lithotripsy System

Interventions

  • DeviceEnhanced Lithotripsy System

    Treatment of urinary stone disease with the Enhanced Lithotripsy System

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Success

    Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging

    Time frame: 30 days

Secondary outcomes

  1. Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)

    Incidence of Serious Device and/or Serious Procedure-Related adverse events

    Time frame: 30 days

07

Results

Posted Apr 3, 2026

Participant flow

Participant flow — Overall Study
MilestoneEnhanced Lithotripsy System
Started25
Completed25
Not completed0

Outcome measures

PrimaryNumber of Participants With Treatment Success

Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment Success
ParticipantsEnhanced Lithotripsy System
Number of Participants With Treatment Success17
SecondaryPercentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)

Incidence of Serious Device and/or Serious Procedure-Related adverse events

Time frame:
30 days
Reported as:
Count of participants · Participants
Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
ParticipantsEnhanced Lithotripsy System
Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)4

Adverse events

Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced Lithotripsy System0/25 (0%)4/25 (16%)12/25 (48%)
Most frequent serious events
Most frequent serious events
EventEnhanced Lithotripsy System
Pain: Flank PainGeneral disorders3/25
Paroxysmal Atrial FibrillationCardiac disorders1/25
HaematuriaRenal and urinary disorders1/25
Myocardia InfarctionCardiac disorders1/25
Other: FractureMusculoskeletal and connective tissue disorders1/25
Most frequent other events
Showing 10 of 18
Most frequent other events
EventEnhanced Lithotripsy System
Pain: Flank PainGeneral disorders2/25
Intermittent Urinary FrequencyRenal and urinary disorders2/25
Urinary Tract / bladder or other infection in the genitourinary systemRenal and urinary disorders2/25
HypotensionCardiac disorders1/25
Altered bowel problemsGastrointestinal disorders1/25
Pain, Other: Hip PainGeneral disorders1/25
Pain, Other: Left Groin PainGeneral disorders1/25
Glucose in UrineRenal and urinary disorders1/25
HaematuriaRenal and urinary disorders1/25
Increased Urinary FrequencyRenal and urinary disorders1/25

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Enhanced Lithotripsy System
<=18 years0
Between 18 and 65 years21
>=65 years4
Age, Continuous
Age, Continuous(years)Enhanced Lithotripsy System
Mean50.3 (27 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Enhanced Lithotripsy System
Female8
Male17
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Enhanced Lithotripsy System
Region of Enrollment
Region of Enrollment(participants)Enhanced Lithotripsy System
Australia25
BMI
BMI(kg/m^2)Enhanced Lithotripsy System
Mean28.79 (19.47 to 39.15)
08

Study locations

4 sites
  • Macarthur Urology
    Campbelltown, New Southwales 2560, Australia
  • Alpha West Mead Private Hospital PTY Limited
    Westmead, New Southwales 2145, Australia
  • Goldfields Urology
    Bendigo, Victoria 3550, Australia
  • Austin Health
    Heidelberg, Victoria 3084, Australia
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2019 to primary completion in Mar 2020, 13 months.

Results were first posted in Apr 2026, 6 years after primary completion.

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

Registered
Feb 7, 2019
First posted
Feb 25, 2021
StartActual
Feb 8, 2019
Primary completionActual
Mar 18, 2020
CompletionActual
Oct 5, 2022
Results first posted
Apr 3, 2026
Last update
Apr 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.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04771182
Lead sponsor
Avvio Medical
Responsible party
Sponsor
First posted
Feb 25, 2021
Start date
Feb 8, 2019
Primary completion
Mar 18, 2020
Completion
Oct 5, 2022
Results posted
Apr 3, 2026
Last update
Apr 3, 2026

Oversight

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

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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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