Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

Avvio Medical

Status: Enrolling

Conditions: Kidney Calculi; Ureteral Calculi

Treatments: Device: ELS (Enhanced Lithotripsy System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06942949

CIP-0002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

Enrollment: 101 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female aged >=21 Years
• Provides written informed consent
• One urinary stone within the ureter, size >=5 mm and <=10 mm
• Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
• Urinary stone is present on a CT scan within past 14 days

Exclusion criteria

• Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
• Medical Expulsion Therapy (e.g., Flomax)
• Non-calcium based stones (e.g., uric acid stones)
• Untreated UTI
• Presence of abnormal skin conditions in the area to be treated
• Coagulation abnormality
• Inability to lay still for 30 minutes
• Pregnant
• Abnormal Kidney Function
• Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

The ELS Trial is a prospective, multi-center, single arm study.

Experimental group

Description:

All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure.

Treatment:

Device: ELS (Enhanced Lithotripsy System)