Fecal Incontinence (FI)
Conditions
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.
Interventions
DEVICEALVIV Laser Treatment
ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.
Sponsors
Alviv Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment/ device related adverse events | From enrollment to the end of study FU visit (~6months) |
Secondary
| Measure | Time frame |
|---|---|
| Successful operation of system with no associated device malfunction | at each study treatment (up to 6 treatments) |
Countries
Israel
Contacts
CONTACTShira Doron
Outcome results
None listed