Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
ConditionFecal Incontinence (FI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlviv Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ALVIV Laser Treatment
DeviceALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: ALVIV TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of treatment/ device related adverse events
Time frame
From enrollment to the end of study FU visit (~6months)Secondary outcomes
1
Successful operation of system with no associated device malfunction
Time frame
at each study treatment (up to 6 treatments) Source ClinicalTrials.gov