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

Study acronym: ELS
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 16, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion pushed from May 2026 to Aug 2026
    • Trial sites expanded: 16 → 20 locations
    • Study completion pushed from Jul 2026 to Sep 2026
    v8
  2. Primary completion date: Oct 2025 to May 2026
    • Study sites: 15 to 16
    • Study completion date: Oct 2025 to Jul 2026
    • Eligibility criteria shortened, about 2 words
    v7
  3. Study sites: 10 to 15v6
  4. Study sites: 6 to 10v5
  5. Study sites: 5 to 6v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 4 to 5v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to May 1, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06942949
Lead Sponsor Avvio Medical
Conditions
(from sponsor)		 Kidney Calculi; Ureteral Calculi
Related terms Kidney Calculi, Ureteral Calculi
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov