BridgeMD
Tests treatment safety and results for Infected Pilonidal Sinus
Official title Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
ClinicalTrials.gov ID: NCT07557589
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patient already included in a type 1 treatment 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...
See the full eligibility 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
- Patient already included in a type 1 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Dax, France
- Mont-de-Marsan, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dax, France; Mont-de-Marsan, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.