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

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

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Stone
• Intervention / Treatment: Device: Enhanced Lithotripsy System

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • McArthur Urology
    • Westmead, New South Wales, Australia, 2145
      • Westmead Private Hospital
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Goldfields Urology
    • Melbourne, Victoria, Australia, 3084
      • Austin Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Lithotripsy System; Treatment of urinary stones with the Enhanced Lithotripsy System	Device: Enhanced Lithotripsy System; Stone treatment with the Enhanced Lithotripsy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free status	Proportion of study participants who are successfully treated [absence of stones or with only clinically-insignificant remaining fragments]	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medication usage	Collection of pain concomitant pain medications	30 days
Time to stone passage	Evaluation of stone presence	30 days
Pain scoring	Patient reported pain scores	30 days

Collaborators and Investigators

• Sponsor: Applaud Medical, Inc.
• Investigators: Principal Investigator: Damien M Bolton, MD, MBBS, Austin Hospital, Melbourne Australia

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: lithotripsy; urinary stone
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 2017-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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