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Recruiting NCT07436676

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

No phase Interventional Fecal Incontinence (FI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALVIV Laser Treatment.
Who it may be relevant to
Registry conditions: Fecal Incontinence (FI). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device ALVIV Laser Treatment
    ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.

Primary outcome measures

  • Number of treatment/ device related adverse events [Time frame: From enrollment to the end of study FU visit (~6months)]
Secondary outcome measures (1)
  • Successful operation of system with no associated device malfunction [Time frame: at each study treatment (up to 6 treatments)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Meir Medical Center — Kfar Saba

Identifiers

NCT: NCT07436676 · CLN-ALV-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗