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โ† Trials
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Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months

RecruitingNAAges 18 Years - anyAllCHI MONT DE MARSAN ET PAYS DES SOURCES
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Radiofrequency treatment
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Where

2 sites
Centre Hospitalier de Dax
Dax, France
CH De Mont de Marsan
Mont-de-Marsan, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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