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

NCT ID: NCT03339388

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-08
• Study Completion Date: 2022-10-05

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.

Conditions

Urinary Stone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Enhanced Lithotripsy System

Treatment of urinary stones with the Enhanced Lithotripsy System

Group Type: EXPERIMENTAL

Enhanced Lithotripsy System

Intervention Type: DEVICE

Stone treatment with the Enhanced Lithotripsy System

Interventions

Enhanced Lithotripsy System

Stone treatment with the Enhanced Lithotripsy System

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avvio Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien M Bolton, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Austin Hospital, Melbourne Australia

Locations

McArthur Urology

Campbelltown, New South Wales, Australia

Westmead Private Hospital

Westmead, New South Wales, Australia

Goldfields Urology

Bendigo, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

2017-03

Identifier Type: -

Identifier Source: org_study_id