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