Urinary StoneNCT03339388
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 extracorporeal 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
- 13 participants
- Where
- 4 sitesAustralia
- Study dates
- 8 Dec 2017to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to ≤ 75 years.
- One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
- Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
- Provides written informed consent
- Understands and accepts the study requirements
Who cannot join
- Age less than 18 years of age or over 75 years of age
- Diagnosis of radiolucent stones
- Diagnosis of stones in the lower pole of kidney
- History of cystinuria
- Urine pH below 5.5
- Current untreated urinary tract infection
Show all 15Show fewer
- Pregnancy
- Coagulation abnormality or taking prescription anticoagulants. 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 30 minutes or unable to roll from back to side
- Known hypersensitivity to conductivity gel
- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- Body mass index greater than 35
- American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
- 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.
- Enrollment in another research study or previous participation within 30 days of enrollment.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Goldfields Urology
Bendigo, Victoria, 3550
McArthur Urology
Campbelltown, New South Wales, 2560
Austin Health
Melbourne, Victoria, 3084
Westmead Private Hospital
Westmead, New South Wales, 2145
About this study
Official title: Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease
This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeal 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 extracorporeal 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
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Lithotripsy SystemDevice
Stone treatment with the Enhanced Lithotripsy System
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Lithotripsy System | Experimental | Treatment of urinary stones 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.
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Incidence of Serious Device and/or Serious Procedure-Related adverse events
Measured: 90 days
Secondary outcomes (1)
Stone-free status
Proportion of study participants who are successfully treated [absence of stones or with only clinically-insignificant remaining fragments]
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 posted13 Nov 2017
- Study start8 Dec 2017
- Primary completion10 Jul 2018
- 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.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avvio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damien M Bolton, MD, MBBS, Principal investigator, Austin Hospital, Melbourne Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339388
- Sponsor's protocol ID
- 2017-03
- Status last verified
- Aug 2021
- First submitted
- 7 Nov 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease
- ClinicalTrials.gov ID
- NCT03339388
- Acronym / sponsor ID
- 2017-03
- Conditions
- Urinary Stone
- Keywords
- lithotripsy, urinary stone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate enrollment has been achieved
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Avvio MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
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 extracorporeal 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 extracorporeal 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 stones 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 (5 listed)
- Male or female aged ≥ 18 years to ≤ 75 years.
- One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
- Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
- Provides written informed consent
- Understands and accepts the study requirements
Key exclusion criteria (15 listed)
- Age less than 18 years of age or over 75 years of age
- Diagnosis of radiolucent stones
- Diagnosis of stones in the lower pole of kidney
- History of cystinuria
- Urine pH below 5.5
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 SystemStone treatment with the Enhanced Lithotripsy System | Device | Enhanced Lithotripsy System |
Primary outcome
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Time frame: 90 days
Incidence of Serious Device and/or Serious Procedure-Related adverse events
1 secondary outcome
Stone-free status
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Adequate enrollment has been achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
Damien M Bolton, MD, MBBS principal investigator
Austin Hospital, Melbourne Australia
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 5 inclusion and 15 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 17 Apr 2024. 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?
The study was stopped early (reason given: Adequate enrollment has been achieved). Results are not available in the source record.
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?
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety) (time frame: 90 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 17 Apr 2024.