An interventional study of ALVIV Laser Treatment in Fecal Incontinence (FI), sponsored by Alviv Ltd.. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Alviv Ltd. · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →This is the only study on the registry with Alviv Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: ALVIV Laser Treatment
ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.
Number of treatment/ device related adverse events
Time frame: From enrollment to the end of study FU visit (~6months)
Successful operation of system with no associated device malfunction
Time frame: at each study treatment (up to 6 treatments)
Plan to share: Undecided — The sponsor does not plan to make individual participant data available to other researchers. The sponsor may consider sharing de-identified individual participant data upon reasonable request and subject to data use agreements.
No publications or documents are linked to this record.
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