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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