Urinary StoneSTONESNCT04771182
Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
A study testing Enhanced Lithotripsy System in people with Urinary Stone, run by Avvio Medical at 4 sites in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Stone
- What is being tested?
- Enhanced Lithotripsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesAustralia
- Study dates
- 8 Feb 2019to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years
- Provides written informed consent
- Understands and accepts the study requirements
- One urinary stone eligible for treatment (minimum) that is:
- apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
- located within the renal pelvis or ureter
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- is ≥ 3 mm in at least one dimension and ≤ 10 mm in maximum
- 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
- Participants with two or more stones in one or both kidneys are admissible and must meet the following inclusion criteria:
- Number of stones (≥ 3 mm) present on treated side is 2 or less
- Untreated stones must not be anticipated to require treatment within 30 days of enrollment, as determined by the investigator
Who cannot join
- Age less than 18 years of age or over 75 years of age
- Diagnosis of radiolucent stones
- History of cystinuria
- Urine pH below 5.5
- Current untreated urinary tract infection
- Pregnancy
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- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Enrollment in another research study or previous participation within 30 days of enrollment.
- Participant has planned general anesthesia during index procedure with American Society of Anesthesiologists (ASA) physical classification level of 3 or greater
- 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
- 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
- Mobility issues - unable to comfortably lie still for up to 120 minutes or unable to roll from back to side
- Known hypersensitivity to conductivity gel
- Body mass index (BMI) ≥ 35 unless anticipated skin to stone distance (anticipated distance from site of ELS treatment head to stone per pre-operative CT) is <135mm
- Implanted spinal cord neurostimulator intrathecal pump or any device that may interfere with energy transmission
- Participant has open wounds, lesions, dermatitis, or ischemic tissues in the treatment area
- Participant has had a major surgery that removed tissue around the spinal cord (e.g. a laminectomy) within the treatment area
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Goldfields Urology
Bendigo, Victoria, 3550
Macarthur Urology
Campbelltown, New Southwales, 2560
Austin Health
Heidelberg, Victoria, 3084
Alpha West Mead Private Hospital PTY Limited
Westmead, New Southwales, 2145
About this study
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.
- Conditions
- Urinary Stone
- Being tested
- Enhanced Lithotripsy System
- Keywords
- lithotripsy, urinary stone, urolithiasis
- Medical subject headings
- Urinary Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Lithotripsy SystemDevice
Treatment of urinary stone disease with the Enhanced Lithotripsy System
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Lithotripsy System | Experimental | Treatment of urinary stone disease with the Enhanced Lithotripsy System Receives: Device: Enhanced Lithotripsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start8 Feb 2019
- Primary completion18 Mar 2020
- Study completion5 Oct 2022
Why it stopped: Adequate enrollment has been achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avvio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771182
- Sponsor's protocol ID
- 2018-01
- Acronym
- STONES
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2019
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
- ClinicalTrials.gov ID
- NCT04771182
- Acronym / sponsor ID
- STONES / 2018-01
- Conditions
- Urinary Stone
- Keywords
- lithotripsy, urinary stone, urolithiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate enrollment has been achieved
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Avvio MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Lithotripsy System | Experimental | Device: Enhanced Lithotripsy SystemTreatment of urinary stone disease with the Enhanced Lithotripsy System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged ≥ 18 years
- Provides written informed consent
- Understands and accepts the study requirements
- One urinary stone eligible for treatment (minimum) that is:
- Participants with two or more stones in one or both kidneys are admissible and must meet the following inclusion criteria:
Key exclusion criteria (18 listed)
- Age less than 18 years of age or over 75 years of age
- Diagnosis of radiolucent stones
- History of cystinuria
- Urine pH below 5.5
- Current untreated urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Lithotripsy SystemTreatment of urinary stone disease with the Enhanced Lithotripsy System | Device | Enhanced Lithotripsy System |
Primary outcome
Number of Participants With Treatment Success
Time frame: 30 days
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
1 secondary outcome
Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Lithotripsy System in people with Urinary Stone, run by Avvio Medical at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Success (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.