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RECRUITING
NCT07436676
NA

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

Sponsor: Alviv Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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