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Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
Sponsor: Alviv Ltd.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-04-03
Completion Date
2026-03
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
ALVIV Laser Treatment
ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.
Locations (1)
Meir Medical Center
Kfar Saba, Israel