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

    • Gujarat
      • Nadiad, Gujarat, India, 387 001
        • Muljibhai Patel Urological Hospital

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
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.

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
Safety: Proportion of subjects with serious device-related adverse events
30 days after last treatment session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful treatment of urinary stone
Time Frame: 14 days after last treatment session
Proportion of subjects with successful treatment or urinary stone
14 days after last treatment session

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
Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
Time to passage of stones
Time Frame: 30 days after last treatment session
Post-Treatment time to passage of stone fragments after treatment
30 days after last treatment session
Pain medication usage
Time Frame: Baseline and Days 1, 2, 3, 7, 14, and 30
Use and quantity of pain medication
Baseline and Days 1, 2, 3, 7, 14, and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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