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

February 26, 2026 updated by: Alviv Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Contact:
        • Principal Investigator:
          • Yaron Rudnicki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALVIV Treatment
Device: ALVIV Laser Treatment
ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment/ device related adverse events
Time Frame: From enrollment to the end of study FU visit (~6months)
From enrollment to the end of study FU visit (~6months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful operation of system with no associated device malfunction
Time Frame: at each study treatment (up to 6 treatments)
at each study treatment (up to 6 treatments)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alviv Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-ALV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sponsor does not plan to make individual participant data available to other researchers. The sponsor may consider sharing de-identified individual participant data upon reasonable request and subject to data use agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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