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Radiofrequency zaps pilonidal sinus: a quicker heal?

NCT ID NCT07557589

Disease control Sponsor: CHI MONT DE MARSAN ET PAYS DES SOURCES Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new radiofrequency treatment for infected pilonidal sinus, a painful skin condition common in young adults. The procedure uses heat to destroy diseased tissue, aiming to heal faster than traditional open surgery. Sixty participants will be followed for 6 months to check safety, effectiveness, and satisfaction.

What this could mean

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

Active substance
radiofrequency treatment (Fistura procedure)
What this could lead to
If successful, this could offer a less invasive, faster-healing option for pilonidal sinus, reducing the need for daily wound care and time off work.
What could go wrong
This is a small, early-stage study with only 60 participants, and the technique is new for this condition. Results may not apply to everyone, and there is a risk of complications like infection or bleeding.

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 60 people

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

Started

Apr 2026

Expected to finish

Feb 2027

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

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: * Patient presenting an infected pilonidal sinus at the exception of acute abscess stage requiring an surgical procedure * Patient aged 18 or above * For Women Of Child Bearing Age, use of efficient contraceptive (less than 1% failure) * Patient with health insurance coverage * French-speaking patient * Patient who has given their free, informed and written consent Exclusion Criteria: * Patient already included in a type 1 interventional research protocol (RIPH1) * Patient with cardiac disease (including pacemaker) * Patient with skin infection * Patient with acute abcess * Patient with suppurated cavity requiring urgent drainage * Patient for whom local or general anesthesia is contraindicated, with an anal infectious disease, or an anal fissure or who have previously had a stapled hemorrhoidopexy (Longo procedure) with metallic staples * Patient treated by aspririn or anticoagulant * Patient with bleeding or coagulation disorder * Allergic patient to nickel and chromium * Pregnant or Breastfeeding women * Patient under guardianship or curatorship * Patient incarcerated * Patient under legal protection * Patient refusing follow-up * Patient for whom MRI is contraindicated

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Conditions

The condition(s) this trial relates to.

Patient Satisfaction pilonidal sinus

As listed by the trial registrant

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

Infected pilonidal sinus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH De Mont de Marsan

    NOT_YET_RECRUITING

    Mont-de-Marsan, 40024, France

  • Centre Hospitalier de Dax

    RECRUITING

    Dax, 40100, France