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Laser zaps leakage: new device tested for bowel control

NCT ID NCT07436676

Symptom relief Sponsor: Alviv Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a laser device (ALVIV) for people with fecal incontinence. Twelve participants will receive 4-6 treatments, three weeks apart, and keep diaries of leakage episodes. The main goal is to check safety and see if the device works without problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALVIV laser device
What this could lead to
If it works, this could offer a non-surgical option to reduce accidental bowel leakage and improve quality of life.
What could go wrong
This is a very early, small study (12 people) focused on safety, not proof of effectiveness. The device may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal incontinence (FI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 4428164, Israel

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