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New absorbable beads aim to plug anal fistulas without major surgery

NCT ID NCT03707769

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This first-in-human study tested whether TIPS microspheres—tiny absorbable beads—can safely help heal perianal fistulas (abnormal tunnels near the anus). Thirteen adults with simple fistulas received the beads during a standard procedure. The main goal was to check safety, with early signs of healing also tracked. Because it's a small, early study, results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TIPS microspheres (a bioabsorbable device made from PLGA, used as a paste)
What this could lead to
If it works, this could offer a new, safer way to help heal perianal fistulas without major surgery.
What could go wrong
This is a very early, small study (13 people) with no control group. The main goal is safety, not proof of effectiveness. Risks include infection, abscess, or need for further surgery.

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

13 people

The number who actually took part.

Started

Mar 2017

Finished

Oct 2025

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

18 years and older

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: * Age 18 years and above * Cryptoglandular perianal fistula * High and low simple trans-sphincteric fistula Exclusion Criteria: * Secondary fistula, including Crohn's disease, carcinoma, radiotherapy, tuberculosis * Evidence of branching fistula anatomy or cavity on MRI * Inter-sphincteric fistula * Low trans-phincterictrans-sphincteric fistula amenable to simple fistulotomy * Immunosuppressed patients * Participants less than 18 years of age * Unable to consent

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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

Contacts and locations

Locations

  • University College London Hospitals

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.