- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195920
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
November 2, 2022 updated by: Applaud Medical, Inc.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gujarat
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Nadiad, Gujarat, India, 387 001
- Muljibhai Patel Urological Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Lithotripsy System
Treatment for urinary stones with the Enhanced Lithotripsy System
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects with serious device-related adverse events (safety)
Time Frame: 30 days after last treatment session
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Safety: Proportion of subjects with serious device-related adverse events
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30 days after last treatment session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful treatment of urinary stone
Time Frame: 14 days after last treatment session
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Proportion of subjects with successful treatment or urinary stone
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14 days after last treatment session
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain score
Time Frame: Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
|
Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain
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Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
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Time to passage of stones
Time Frame: 30 days after last treatment session
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Post-Treatment time to passage of stone fragments after treatment
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30 days after last treatment session
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Pain medication usage
Time Frame: Baseline and Days 1, 2, 3, 7, 14, and 30
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Use and quantity of pain medication
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Baseline and Days 1, 2, 3, 7, 14, and 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mahesh Desai, MS, FRCS, Muljibhai Patel Urological Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2017
Primary Completion (Actual)
June 25, 2018
Study Completion (Actual)
October 5, 2022
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 21, 2017
First Posted (Actual)
June 22, 2017
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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