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Fistula-Tract laser closure (FiLaC) combined with perilesional autologous PRGF-Endoret injection for Multi-Recurrent cryptoglandular perianal fistula: a prospective Single-Arm pilot study

NCT ID NCT07810075

NEW Sponsor: Complejo Hospitalario Universitario de Santiago Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cryptoglandular perianal fistula with at least 2 previous documented surgical failures * Parks classification: intersphincteric or transsphincteric (low or high) * Seton drain in situ for a minimum of 6 months at the time of surgery * No active perianal sepsis (no purulent discharge, abscess or cellulitis) * Single fistula tract on endoanal ultrasound (no secondary tracts) * Identifiable internal opening on preoperative assessment * Age 18 years or older * Platelet count 100,000/µL or above on preoperative blood test * Signed written informed consent Exclusion Criteria: * Crohn's disease or ulcerative colitis * Suprasphincteric or horseshoe fistula * Active perianal abscess or sepsis at the time of surgery * Secondary fistula tracts on endoanal ultrasound * Coagulopathy or thrombocytopenia (platelet count below 100,000/µL) * Non-suspendable anticoagulant or antiplatelet therapy * Active malignancy or severe immunosuppression * Pregnancy * Preoperative Wexner continence score 8 or above

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Conditions

The condition(s) this trial relates to.

anal fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perianal fistula

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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