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

Urinary Stone Clinical Trial

Official title:

Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03339388
• Other study ID #: 2017-03
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: October 5, 2022

Study information

• Verified date: August 2021
• Source: Applaud Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 5, 2022
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

Device:
• Enhanced Lithotripsy System
Stone treatment with the Enhanced Lithotripsy System

Locations

Country	Name	City	State
Australia	Goldfields Urology	Bendigo	Victoria
Australia	McArthur Urology	Campbelltown	New South Wales
Australia	Austin Health	Melbourne	Victoria
Australia	Westmead Private Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Applaud Medical, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain medication usage	Collection of pain concomitant pain medications	30 days
Other	Time to stone passage	Evaluation of stone presence	30 days
Other	Pain scoring	Patient reported pain scores	30 days
Primary	Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)	Incidence of Serious Device and/or Serious Procedure-Related adverse events	90 days
Secondary	Stone-free status	Proportion of study participants who are successfully treated [absence of stones or with only clinically-insignificant remaining fragments]	30 days