Back to resultsFeasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Primary Purpose
Urinary Stone
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Enhanced Lithotripsy System
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stone
Eligibility Criteria
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
Sites / Locations
- Muljibhai Patel Urological Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enhanced Lithotripsy System
Arm Description
Treatment for urinary stones with the Enhanced Lithotripsy System
Outcomes
Primary Outcome Measures
Proportion of subjects with serious device-related adverse events (safety)
Safety: Proportion of subjects with serious device-related adverse events
Secondary Outcome Measures
Successful treatment of urinary stone
Proportion of subjects with successful treatment or urinary stone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195920
Brief Title
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Official Title
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Interim data was sufficient for study purpose
Study Start Date
July 22, 2017 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applaud Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm trial with the Enhanced Lithotripsy System
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Lithotripsy System
Arm Type
Experimental
Arm Description
Treatment for urinary stones with the Enhanced Lithotripsy System
Intervention Type
Device
Intervention Name(s)
Enhanced Lithotripsy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects with serious device-related adverse events (safety)
Description
Safety: Proportion of subjects with serious device-related adverse events
Time Frame
30 days after last treatment session
Secondary Outcome Measure Information:
Title
Successful treatment of urinary stone
Description
Proportion of subjects with successful treatment or urinary stone
Time Frame
14 days after last treatment session
Other Pre-specified Outcome Measures:
Title
Change in pain score
Description
Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain
Time Frame
Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
Title
Time to passage of stones
Description
Post-Treatment time to passage of stone fragments after treatment
Time Frame
30 days after last treatment session
Title
Pain medication usage
Description
Use and quantity of pain medication
Time Frame
Baseline and Days 1, 2, 3, 7, 14, and 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahesh Desai, MS, FRCS
Organizational Affiliation
Muljibhai Patel Urological Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiad
State/Province
Gujarat
ZIP/Postal Code
387 001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
We'll reach out to this number within 24 hrs