ALVIV laser treatment for fecal incontinence — safety and feasibility

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

This trial will try the ALVIV laser treatment in adults with fecal incontinence to see if it is safe and reduces incontinence episodes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alviv Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Kfar Saba)
• Trial ID: NCT07436676 on ClinicalTrials.gov

What this trial studies

This first-in-human interventional study tests the safety and performance of the ALVIV laser system in patients with fecal incontinence. After screening, eligible participants will receive 4–6 outpatient laser treatments spaced three weeks apart, with the final study visit occurring three weeks after the last treatment. Participants will keep a diary of incontinence episodes and complete quality-of-life and satisfaction questionnaires throughout the study. Key eligibility limits include at least six months of symptoms, recent normal colonoscopy or sigmoidoscopy, and exclusion for significant rectal/anal pathology, inflammatory bowel disease, recent pelvic surgery, pregnancy, or existing implants.

Who should consider this trial

Good fit: Adults with at least six months of fecal incontinence who report at least 2–4 staining, solid, or liquid episodes in the four weeks before enrollment and who meet screening exams (including a recent normal colonoscopy) are the intended participants.

Not a fit: Patients with significant anorectal disease (for example rectal prolapse grade ≥III, hemorrhoids grade ≥II), recent obstetrical third- or fourth-degree tears, large sphincter defects on imaging, inflammatory bowel disease, recent pelvic surgery or radiation, existing anal or rectal implants, or those who are pregnant or breastfeeding are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the treatment could reduce fecal incontinence episodes and improve quality of life with a minimally invasive outpatient approach.

How similar studies have performed: This is a first-in-human trial and laser-based treatments for fecal incontinence have limited prior clinical evidence, so efficacy has not been established widely.

Eligibility criteria

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.

Where this trial is running

Kfar Saba

• Meir Medical Center — Kfar Saba, Israel (Recruiting)

Study contacts

• Study coordinator: Shira Doron

Conditions Fecal Incontinence