Minimally invasive treatment for anal fistulas with a seton
Part of Digestive system clinical trials.
This trial tests whether RD2 Ver.02 is safe and works better than a comparison treatment for treating anal fistulas using a less invasive approach. It may help people who have a seton in place and want to avoid major surgery like flap repair or LIFT.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are at least 18 years old
- You have a transsphincteric or long intersphincteric anal fistula longer than 1.5 cm, and a seton has been in place for at least 1 month
- Your MRI shows a fistula with one outside opening and one inside opening (not multiple tracts)
- You cannot or do not want major fistula surgery (like flap repair or LIFT), and you choose a less invasive method instead
- You must be able to do an MRI of the pelvis within 3 months before starting
- If you could become pregnant, you must use reliable birth control during the study and for 6 months after
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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Other trials that look related to this one.
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This study follows people having surgery for an anal fistula to see how well they recover. It uses your feedback to measure results, and you'll have check-ins for a year.
This study tests whether placing a temporary seton (a soft thread) before surgery helps improve healing for people with a single anal fistula, compared to going straight to surgery. It aims to see if this approach leads to better outcomes and fewer problems.
This trial tests a hydrogel made from natural materials to help heal a specific type of anal fistula. It may be an option if you have a single high transsphincteric fistula with a seton in place for at least four weeks.
This study tests a surgical technique for treating high anal fistulas, which are tunnels that form between the anal canal and the skin. The procedure aims to drain the fistula and preserve muscle function, potentially reducing the risk of incontinence.
This trial tests a new procedure called Fistura to treat complex anal fistulas (abnormal tunnels between the anal canal and skin). It uses radiofrequency energy to close the fistula while preserving muscle. The study is for people whose fistula has already been drained with a temporary seton stitch.
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