Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months (RFKP)

May 22, 2026 updated by: Ch Mont de Marsan

Infected pilonidal sinus is a common suppuration that occurs twice as often in men as in women, usually between the ages of 15 and 30. Clinical diagnosis is easy, whether the presentation is acute or chronic. Exeresis with a wound left open requiring secondary postoperative healing is the most widely practiced technique in France because its recurrence rate is the lowest, but it has the disadvantage of requiring daily or even twice-daily local nursing care, long healing, and a break in activity.

In order to limit the disadvantages of the open technique, "conservative" minimally invasive techniques have also recently been developed in response to strong patient demand: such as endoscopic treatment (EPSIT = Endoscopic Pilonidal Sinus Treatment, or VAAPS = Video-Assisted Ablation of Pilonidal Sinus), or the SiLaT (Sinus Laser Therapy) laser.

More recently, radiofrequency has emerged as a new technique in the treatment of hemorrhoidal pathology according to the Rafaelo procedure as well as the Fistura procedure for anal fistulas. The principle of the treatment is similar to that of the laser, based on radio frequency thermocoagulation using very high frequency electromagnetic waves (4MHz), similar to the principle of microwaves. However, its use in the infected pilonidal sinus has not yet been described. The fibers used in anal fistulas are perfectly adapted to the treatment of the pilonidal sinus. In addition, and in contrast to the laser, several fiber diameters are available depending on the size of the fistula path(s). For example, the large diameters of 9 Fr seem to be more adapted to the deep and wide cavities of the pilonidal sinuses than those of the SiLaT, which has a single fiber diameter. The investigators can therefore think that this type of fibers could allow a more efficient destruction of the granulation tissues and a better docking of the cavity walls.

According to published studies in the treatment of anal fistulas, the safety profile of this treatment is perfectly reassuring since the penetrance of the energy released does not exceed 3 mm in depth.

The aim of this study is to evaluate the radiofrequency treatment according to the Fistura® procedure, by mesure its safety, efficacy and patient satisfaction on a series of consecutive patients treated for infected sinus pilonidal.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dax, France, 40100
      • Mont-de-Marsan, France, 40024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency using the Fistura procedure
Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus
Device: Radiofrequency treatment
Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of radiofrequency treatment safety
Time Frame: Within 15days after the radiofrequency treatment
Incidence rate of at least one complication of the radiofrequency treatment : incidence rate of of haemorrhagic complication, incidence rate of acute urinary retention and incidence rate of others complications such as post radiofrequency treatment abcess, haematoma, localized infection.
Within 15days after the radiofrequency treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of radiofrequency treatment safety
Time Frame: Within 15days after the radiofrequency treatment
Incidence rate of of haemorrhagic complication after the radiofrequency treatment
Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Time Frame: Within 15days after the radiofrequency treatment
Incidence rate of acute urinary retention after the radiofrequency treatment
Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Time Frame: Within 15days after the radiofrequency treatment
Incidence rate of others complications such as post radiofrequency treatment abcess, haematoma, localized infection.
Within 15days after the radiofrequency treatment
Evaluation of post radiofrequency pain
Time Frame: Within 15days after the radiofrequency treatment
Patient will be asked daily to evaluate post surgery pain using a Numerical Rating Scale (NRS). Patients will be asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero represents 'no pain at all' whereas10 represents 'the worst pain ever possible'.
Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment efficiency
Time Frame: 6 months after the radiofrequency treatment

During the last patient visit, a clinical evaluation will be performed during which closure of all existing fistula external opening will be assessed (Yes or No), as well as the absence or presence of abcess and new external opening (Yes or no) . The patient will be asked to evaluate the presence or absence of pain (yes or no)

The Treatment will be evaluated as efficient if there is closure of all fistula external opening AND absence of pain AND absence of abscess or new external opening.
6 months after the radiofrequency treatment
Length of the medical leave after the radiofrequency treatment
Time Frame: Within 6 months after the radiofrequency treatment
Record of number of medical leave days prescribed after the radiofrequency treatment Record of number of day after the radiofrequency treatmenty necessary before returning to normal activity.
Within 6 months after the radiofrequency treatment
Measurement of patient satisfaction after the radiofrequency treatment
Time Frame: At 1 mont and 6 months after the radiofrequency treatment
Each patient will evaluate their satisfaction regarding their radiofrequency treatment using a visual 5 point scale ranking from "very unsatified" to "very satisfied"
At 1 mont and 6 months after the radiofrequency treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ch Mont de Marsan

Collaborators

Centre Hospitalier de Dax

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02155-42B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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