Urinary StoneNCT03195920
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
A study testing Enhanced Lithotripsy System in people with Urinary Stone, run by Avvio Medical at 1 site in India.
Trial summary
This is a single arm, single 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 years and older
- 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
- 3 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
- Males and females aged 18 or older
- Capable of giving informed consent, and willing to have the informed consent process videotaped
- Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.
Who cannot join
- Individuals under 18 years of age
- Individuals with radiolucent stones
- Individuals with stones in the lower pole of kidney
- Individuals not following up in the treating hospital
- Individuals with history of cystinuria
- Individuals with urine pH below 5.5
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- Individuals with untreated urinary tract infection
- Individuals who are not willing to use adequate method of contraception during the study period
- Women who are pregnant, lactating or planning pregnancy during the study period
- Individuals with a coagulation abnormality or taking prescription anticoagulants.
- Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
- Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
- Individuals with a body mass index greater than 35
- Individuals with ASA score of 3 or greater general anesthesia risk level
- Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
Trial locations and contacts
1 site in 1 country.
About this study
This is a single arm, single 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, single 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 30 days after the last treatment session.
- Conditions
- Urinary Stone
- Being tested
- Enhanced Lithotripsy System
- 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
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Lithotripsy System | Experimental | Treatment for 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 subjects with serious device-related adverse events (safety)
Safety: Proportion of subjects with serious device-related adverse events
Measured: 30 days after last treatment session
Secondary outcomes (1)
Successful treatment of urinary stone
Proportion of subjects with successful treatment or urinary stone
Measured: 14 days after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start22 Jul 2017
- Primary completion25 Jun 2018
- Study completion5 Oct 2022
Why it stopped: Interim data was sufficient for study purpose
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
- Model description
- Single arm trial with the Enhanced Lithotripsy System
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avvio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahesh Desai, MS, FRCS, Principal investigator, Muljibhai Patel Urological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195920
- Sponsor's protocol ID
- 2017-02
- Status last verified
- Apr 2024
- First submitted
- 20 Jun 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
- Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
- ClinicalTrials.gov ID
- NCT03195920
- Acronym / sponsor ID
- 2017-02
- Conditions
- Urinary Stone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim data was sufficient for study purpose
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Avvio MedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 22 Jun 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, single 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, single 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 30 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
- Model description
- Single arm trial with the Enhanced Lithotripsy System
| Arm | Type | Receives |
|---|---|---|
| Enhanced Lithotripsy System | Experimental | Device: Enhanced Lithotripsy SystemTreatment for urinary stones with the Enhanced Lithotripsy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
- Males and females aged 18 or older
- Capable of giving informed consent, and willing to have the informed consent process videotaped
- Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.
Key exclusion criteria (15 listed)
- Individuals under 18 years of age
- Individuals with radiolucent stones
- Individuals with stones in the lower pole of kidney
- Individuals not following up in the treating hospital
- Individuals with history of cystinuria
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 SystemThe Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones. | Device | Enhanced Lithotripsy System |
Primary outcome
Proportion of subjects with serious device-related adverse events (safety)
Time frame: 30 days after last treatment session
Safety: Proportion of subjects with serious device-related adverse events
1 secondary outcome
Successful treatment of urinary stone
Time frame: 14 days after last treatment session
Results and safety
The study was stopped early (reason given: Interim data was sufficient for study purpose). 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: Undecided
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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.
Mahesh Desai, MS, FRCS principal investigator
Muljibhai Patel Urological Hospital
1 site 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 1 site in India.
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 4 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 1 site in India. 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: Interim data was sufficient for study purpose). 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 subjects with serious device-related adverse events (safety) (time frame: 30 days after last treatment session). 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.