Infected Pilonidal SinusRFKPNCT07557589
Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
A study testing Radiofrequency treatment in people with Infected Pilonidal Sinus, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Pilonidal Sinus
- What is being tested?
- Radiofrequency treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Apr 2026to Feb 2027
- 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
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de Dax
Dax, 40100
Anne-Hélène BOIVIN, 0558052909, recherche-clinique@ght40.fr
Vanessa LATRY, 0558916469, vanessa.latry@ght40.fr
- Not yet recruiting
CH De Mont de Marsan
Mont-de-Marsan, 40024
Anne-Hélène BOIVIN, 0558052909, recherche-clinique@ght40.fr
Vanessa LATRY, vanessa.latry@ght40.fr
About this study
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.
Read more
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.
- Conditions
- Infected Pilonidal Sinus
- Being tested
- Radiofrequency treatment
- Keywords
- Infected Pilonidal Sinus, Radiofrequency, Safety, Efficacy, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency treatmentDevice
Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency using the Fistura procedure | Experimental | Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus Receives: Device: Radiofrequency treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of radiofrequency treatment safety
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.
Measured: Within 15days after the radiofrequency treatment
Secondary outcomes (7)
Evaluation of radiofrequency treatment safety
Incidence rate of of haemorrhagic complication after the radiofrequency treatment
Measured: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Incidence rate of acute urinary retention after the radiofrequency treatment
Measured: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Incidence rate of others complications such as post radiofrequency treatment abcess, haematoma, localized infection.
Measured: Within 15days after the radiofrequency treatment
Evaluation of post radiofrequency pain
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'.
Measured: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment efficiency
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.
Measured: 6 months after the radiofrequency treatment
Length of the medical leave 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.
Measured: Within 6 months after the radiofrequency treatment
Measurement of patient satisfaction 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"
Measured: At 1 mont and 6 months after the radiofrequency treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start24 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Infected Pilonidal SinusStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCES
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Dax
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557589
- Sponsor's protocol ID
- 2024-A02155-42B
- Acronym
- RFKP
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merlini l'Heritier A, Siproudhis L, Bessi G, Le Balc'h E, Wallenhorst T, Bouguen G, Brochard C. Sphincter-sparing surgery for complex anal fistulas: radiofrequency thermocoagulation of the tract is of no help. Colorectal Dis. 2019 Aug;21(8):961-966. doi: 10.1111/codi.14618. Epub 2019 Apr 3.
PubMed 30897291Spindler L, Alam A, Fathallah N, Rentien AL, Draullette M, Pommaret E, Thierry ML, Mituialy AE, Abbes L, Aubert M, Benfredj P, Far ES, Beaussier H, de Parades V. Extensive suppuration and being overweight are factors associated with the failure of laser treatment for pilonidal disease: lessons from the first French retrospective cohort. Tech Coloproctol. 2022 Feb;26(2):143-146. doi: 10.1007/s10151-021-02552-2. Epub 2021 Dec 2.
PubMed 34855026Keogh KM, Smart NJ. The proposed use of radiofrequency ablation for the treatment of fistula-in-ano. Med Hypotheses. 2016 Jan;86:39-42. doi: 10.1016/j.mehy.2015.11.019. Epub 2015 Nov 26.
PubMed 26804594Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.
PubMed 31399891Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
PubMed 28056720Sluckin TC, Hazen SJA, Smeenk RM, Schouten R. Sinus laser-assisted closure (SiLaC(R)) for pilonidal disease: results of a multicentre cohort study. Tech Coloproctol. 2022 Feb;26(2):135-141. doi: 10.1007/s10151-021-02550-4. Epub 2022 Jan 7.
PubMed 34993686Romic I, Augustin G, Bogdanic B, Bruketa T, Moric T. Laser treatment of pilonidal disease: a systematic review. Lasers Med Sci. 2022 Mar;37(2):723-732. doi: 10.1007/s10103-021-03379-x. Epub 2021 Jul 22.
PubMed 34291332Meinero P, La Torre M, Lisi G, Stazi A, Carbone A, Regusci L, Fasolini F. Endoscopic pilonidal sinus treatment (EPSiT) in recurrent pilonidal disease: a prospective international multicenter study. Int J Colorectal Dis. 2019 Apr;34(4):741-746. doi: 10.1007/s00384-019-03256-8. Epub 2019 Feb 4.
PubMed 30719564Velotti N, Manigrasso M, Di Lauro K, Araimo E, Calculli F, Vertaldi S, Anoldo P, Aprea G, Simone G, Vitiello A, Musella M, Milone M, De Palma GD, Milone F, Sosa Fernandez LM. Minimally Invasive Pilonidal Sinus Treatment: A Narrative Review. Open Med (Wars). 2019 Aug 7;14:532-536. doi: 10.1515/med-2019-0059. eCollection 2019.
PubMed 31428682
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
- ClinicalTrials.gov ID
- NCT07557589
- Acronym / sponsor ID
- RFKP / 2024-A02155-42B
- Conditions
- Infected Pilonidal Sinus
- Keywords
- Infected Pilonidal Sinus, Radiofrequency, Safety, Efficacy, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCESUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Dax
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency using the Fistura procedure | Experimental | Device: Radiofrequency treatmentRadiofrequency using the Fistura procedure for treatment of infected pilonidal sinus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Radiofrequency treatmentRadiofrequency using the Fistura procedure for treatment of infected pilonidal sinus | Device | Radiofrequency using the Fistura procedure |
Primary outcome
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.
7 secondary outcomes
Evaluation of radiofrequency treatment safety
Time frame: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Time frame: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment safety
Time frame: Within 15days after the radiofrequency treatment
Evaluation of post radiofrequency pain
Time frame: Within 15days after the radiofrequency treatment
Evaluation of radiofrequency treatment efficiency
Time frame: 6 months after the radiofrequency treatment
Length of the medical leave after the radiofrequency treatment
Time frame: 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
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 May 2026.
- Background: PubMed 30897291Merlini l'Heritier A, Siproudhis L, Bessi G, Le Balc'h E, Wallenhorst T, Bouguen G, Brochard C. Sphincter-sparing surgery for complex anal fistulas: radiofrequency thermocoagulation of the tract is of no help. Colorectal Dis. 2019 Aug;21(8):961-966. doi: 10.1111/codi.14618. Epub 2019 Apr 3.
- Background: PubMed 34855026Spindler L, Alam A, Fathallah N, Rentien AL, Draullette M, Pommaret E, Thierry ML, Mituialy AE, Abbes L, Aubert M, Benfredj P, Far ES, Beaussier H, de Parades V. Extensive suppuration and being overweight are factors associated with the failure of laser treatment for pilonidal disease: lessons from the first French retrospective cohort. Tech Coloproctol. 2022 Feb;26(2):143-146. doi: 10.1007/s10151-021-02552-2. Epub 2021 Dec 2.
- Background: PubMed 26804594Keogh KM, Smart NJ. The proposed use of radiofrequency ablation for the treatment of fistula-in-ano. Med Hypotheses. 2016 Jan;86:39-42. doi: 10.1016/j.mehy.2015.11.019. Epub 2015 Nov 26.
- Background: PubMed 31399891Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.
- Background: PubMed 28056720Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
- Background: PubMed 34993686Sluckin TC, Hazen SJA, Smeenk RM, Schouten R. Sinus laser-assisted closure (SiLaC(R)) for pilonidal disease: results of a multicentre cohort study. Tech Coloproctol. 2022 Feb;26(2):135-141. doi: 10.1007/s10151-021-02550-4. Epub 2022 Jan 7.
- Background: PubMed 34291332Romic I, Augustin G, Bogdanic B, Bruketa T, Moric T. Laser treatment of pilonidal disease: a systematic review. Lasers Med Sci. 2022 Mar;37(2):723-732. doi: 10.1007/s10103-021-03379-x. Epub 2021 Jul 22.
- Background: PubMed 30719564Meinero P, La Torre M, Lisi G, Stazi A, Carbone A, Regusci L, Fasolini F. Endoscopic pilonidal sinus treatment (EPSiT) in recurrent pilonidal disease: a prospective international multicenter study. Int J Colorectal Dis. 2019 Apr;34(4):741-746. doi: 10.1007/s00384-019-03256-8. Epub 2019 Feb 4.
- Background: PubMed 31428682Velotti N, Manigrasso M, Di Lauro K, Araimo E, Calculli F, Vertaldi S, Anoldo P, Aprea G, Simone G, Vitiello A, Musella M, Milone M, De Palma GD, Milone F, Sosa Fernandez LM. Minimally Invasive Pilonidal Sinus Treatment: A Narrative Review. Open Med (Wars). 2019 Aug 7;14:532-536. doi: 10.1515/med-2019-0059. eCollection 2019.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency treatment in people with Infected Pilonidal Sinus, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 2 sites in France.
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 6 inclusion and 15 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of radiofrequency treatment safety (time frame: Within 15days after the radiofrequency treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557589, which also lists 9 linked publications.
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 May 2026.