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

Conditions

• Kidney Calculi; Ureteral Calculi

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ELS (Enhanced Lithotripsy System) — DEVICE
  ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.

Study Details

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. Subjects who still have stone present at Day 30 will be evaluated again at Day 60. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

Key Dates

Start date

May 1, 2025

Status verified

Apr 2025

Primary completion

May 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

101 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: The ELS Trial is a prospective, multi-center, single arm study.
  All Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure.

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: From ELS treatment to 30 Days afterward. ]

Central Contacts

• Louis Marcoux
  415-887-2037
  [email protected]

Locations (16)

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