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

NCT07436676 | Recruiting

• 1 other identifier: CLN-ALV-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Number of treatment/ device related adverse events

  From enrollment to the end of study FU visit (~6months)

Secondary Outcomes (1)

• Successful operation of system with no associated device malfunction

  at each study treatment (up to 6 treatments)

Study Arms (1)

ALVIV Treatment

EXPERIMENTAL

Device: ALVIV Laser Treatment

Interventions

ALVIV Laser Treatment DEVICE

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

ALVIV Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of symptoms for uncontrolled passage of fecal material for at least 6 months prior to enrollment.
• At least 2-4 staining, solid or liquid FI episodes in the 4 weeks prior to enrollment
• Documented normal colonoscopy in the last 3 years
• Normal sigmoidoscopy as part of screening
• Signed consent

You may not qualify if:

• Pregnant or breastfeeding women
• Rectal prolapse grade ≥ III
• Hemorrhoids Grade ≥ II.
• Obstetrical injuries including third- and fourth-degree tears in the anal sphincter within the past 6 months
• Internal anal sphincter separation \>270 degrees on Transrectal Ultrasound (TRUS).
• Congenital malformation of anus or rectum
• History of pelvic surgery in the past 6 months.
• inflammatory bowel disease.
• Presence of Intestinal stoma
• History of pelvic radiation within the previous 12 months or presence of active radiation proctitis.
• Presence of existing implant in the anal or rectal region.
• Active anal or rectal conditions in the last 6 months
• Abnormal blood coagulation
• Patients currently receiving immunotherapy or chemotherapy.

Sponsors & Collaborators

• Alviv Ltd.: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4428164, Israel

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Shira Doron

CONTACT

+972 54-901-1134; shira@alvivlaser.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: April 3, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IL (1)