IRB Study Number 23-672
Status Recruiting
Location Cleveland Clinic Weston Hospital
Institute Digestive Disease & Surgery Institute
Description
This study is for adults with an anal fistula (an abnormal tunnel between the anal canal and the skin) that runs through or alongside the anal sphincter muscles.
The study is testing a device called RD2 Ver.02, which uses your own blood to create a clot that is placed inside the fistula tract. The clot forms a natural fibrin matrix that may help the fistula heal.
All patients have the fistula cleaned (debrided) and the internal opening closed with stitches, followed by a water leak test to confirm it is sealed. Then participants are randomly assigned (like a coin flip) to one of two groups:
Treatment group: the doctor fills the fistula tract with a clot made from your own blood using the RD2 Ver.02 system.
Control group: the doctor fills the fistula tract with saline (salt water) instead of the blood clot.
You will return for 2 study visits during the first month after the procedure and then follow-up visits at about 2, 3, 6, and 12 months. At these visits, the team will examine the fistula area, ask about symptoms and pain, and check whether the fistula has healed or come back.
Inclusion Criteria
Age 18 years or older
Have a diagnosis of an anal fistula that is:
transsphincteric, or
long intersphincteric
Fistula is suitable for surgical cleaning (debridement), closure of the internal opening with stitches, and filling of the tract with study material
Able to understand the study and provide informed consent
Willing and able to return for follow-up visits for up to 12 months after the procedure
Exclusion Criteria
Anal fistula types other than transsphincteric or long intersphincteric (for example, isolated superficial fistulas that do not meet the study definition)
Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate or make follow-up unlikely
Unable or unwilling to give informed consent or attend follow-up visits
