Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Not Applicable

Terminated

• Conditions: Urinary Stone
• Interventions: Device: Enhanced Lithotripsy System

• Registration Number: NCT03195920
• Lead Sponsor: Avvio Medical

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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2017-07-22
• Primary Completion: 2018-06-25
• Study Completion: 2022-10-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced Lithotripsy System	Enhanced Lithotripsy System	Treatment for urinary stones with the Enhanced Lithotripsy System

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with serious device-related adverse events (safety)	30 days after last treatment session	Safety: Proportion of subjects with serious device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Successful treatment of urinary stone	14 days after last treatment session	Proportion of subjects with successful treatment or urinary stone

Trial Locations

Locations (1)

Muljibhai Patel Urological Hospital; 🇮🇳 Nadiad, Gujarat, India