This record was last updated February 27, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose if this interventional First in Human study is to assess the Safety and Performance of the ALVIV System laser based treatment in patients diagnosed with Fecal Incontinence.
Eligible patients will go through screening assessments, followed by a series of 4-6 treatments with 3 weeks apart. Last follow up visit to the study will occur 3 weeks after last treatment day.
Participants will be asked to maintain a diary of their fecal incontinence episodes, and complete quality of life and satisfaction questionnaires throughout the study.
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-22.