NCT07436676

Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Alviv Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence (FI)

Interventions

Type	Name	Description
DEVICE	ALVIV Laser Treatment	ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.

Timeline

• Start date: 2024-04-03
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Israel