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

NCT03339388 | Terminated FDA Device

• 1 other identifier: 2017-03
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

Urinary Stone

Keywords

lithotripsy; urinary stone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stone-free status

  30 days

Other Outcomes (3)

• Pain medication usage

  30 days

• Time to stone passage

  30 days

• Pain scoring

  30 days

Study Arms (1)

Enhanced Lithotripsy System

EXPERIMENTAL

Treatment of urinary stones with the Enhanced Lithotripsy System

Device: Enhanced Lithotripsy System

Interventions

Enhanced Lithotripsy System DEVICE

Stone treatment with the Enhanced Lithotripsy System

Enhanced Lithotripsy System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avvio Medical: lead

Study Sites (4)

McArthur Urology

Campbelltown, New South Wales, 2560, Australia

Location

Westmead Private Hospital

Westmead, New South Wales, 2145, Australia

Location

Goldfields Urology

Bendigo, Victoria, 3550, Australia

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien M Bolton, MD, MBBS

  Austin Hospital, Melbourne Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 13, 2017
• Study Start: December 8, 2017
• Primary Completion: July 10, 2018
• Study Completion: October 5, 2022
• Last Updated: April 17, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)