Actively Recruiting
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
Led by Alviv Ltd. · Updated on 2026-02-27
12
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 fecal incontinence 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 will not qualify if you...
- Pregnant or breastfeeding women
- Rectal prolapse grade 65 III
- Hemorrhoids Grade 65 II
- Obstetrical injuries including third- and fourth-degree tears in the anal sphincter within the past 6 months
- Internal anal sphincter separation greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
Research Team
S
Shira Doron
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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