Fecal Incontinence (FI)NCT07436676
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
A study testing ALVIV Laser Treatment in people with Fecal Incontinence (FI), run by Alviv Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence (FI)
- What is being tested?
- ALVIV Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Apr 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Lee Abramas, +972-9-7471017, meleeabr@clalit.org.il
Yaron Rudnicki, MD
About this study
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.
- Conditions
- Fecal Incontinence (FI)
- Being tested
- ALVIV Laser Treatment
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVIV Laser TreatmentDevice
ALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area.
| Study group | Role | What they receive |
|---|---|---|
| ALVIV Treatment | Experimental | Not described Receives: Device: ALVIV Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment/ device related adverse events
Measured: From enrollment to the end of study FU visit (~6months)
Secondary outcomes (1)
Successful operation of system with no associated device malfunction
Measured: at each study treatment (up to 6 treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Apr 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Incontinence (FI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alviv Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436676
- Sponsor's protocol ID
- CLN-ALV-001
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
- ClinicalTrials.gov ID
- NCT07436676
- Acronym / sponsor ID
- CLN-ALV-001
- Conditions
- Fecal Incontinence (FI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alviv Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALVIV Treatment | Experimental | Device: ALVIV Laser Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALVIV Laser TreatmentALVIV Laser-based treatment for Fecal Incontinence (FI). Treatment is delivered to the Internal Anal Sphincter (IAS) area. | Device | ALVIV Treatment |
Primary outcome
Number of treatment/ device related adverse events
Time frame: From enrollment to the end of study FU visit (~6months)
1 secondary outcome
Successful operation of system with no associated device malfunction
Time frame: at each study treatment (up to 6 treatments)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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.
Related trials for Fecal Incontinence (FI)
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Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
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Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALVIV Laser Treatment in people with Fecal Incontinence (FI), run by Alviv Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shira Doron (+972 54-901-1134, shira@alvivlaser.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment/ device related adverse events (time frame: From enrollment to the end of study FU visit (~6months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.