Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease

Not Applicable

Terminated

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

• Registration Number: NCT03339388
• Lead Sponsor: Avvio Medical

Brief Summary

This is a single arm, multi-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, multi-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 90 days after the last treatment session.

Study Timeline

• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-12-08
• Primary Completion: 2018-07-10
• Status Verified: 2021-08
• Study Completion: 2022-10-05
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Male or female aged ≥ 18 years to ≤ 75 years.
• One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
• Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
• Provides written informed consent
• Understands and accepts the study requirements

Exclusion Criteria

• Age less than 18 years of age or over 75 years of age
• Diagnosis of radiolucent stones
• Diagnosis of stones in the lower pole of kidney
• History of cystinuria
• Urine pH below 5.5
• Current untreated urinary tract infection
• Pregnancy
• Coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician.
• Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to roll from back to side
• Known hypersensitivity to conductivity gel
• Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
• Body mass index greater than 35
• American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
• Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics.
• Enrollment in another research study or previous participation within 30 days of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)	90 days	Incidence of Serious Device and/or Serious Procedure-Related adverse events

Secondary Outcome Measures

Name	Time	Method
Stone-free status	30 days	Proportion of study participants who are successfully treated \[absence of stones or with only clinically-insignificant remaining fragments\]

Trial Locations

Locations (4)

Westmead Private Hospital; 🇦🇺 Westmead, New South Wales, Australia

Austin Health; 🇦🇺 Melbourne, Victoria, Australia

Goldfields Urology; 🇦🇺 Bendigo, Victoria, Australia

McArthur Urology; 🇦🇺 Campbelltown, New South Wales, Australia