A Multi-Center, Double Blind, Randomized Study Comparing RD2 Ver.02 and Saline for Treating Anal Fistulas

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a device called RD2 Ver.02 compared to a control treatment for managing transsphincteric and long intersphincteric anal fistulas. The study aims to assess the complication rate within 6 months, recurrence rates at 12 months after treatment, and the incidence of perirectal infection by 6 months. This is a prospective, multi-center, double-blind, randomized controlled trial conducted by RedDress Ltd. Participants will be randomly assigned to one of two groups. Both groups will undergo debridement of the fistula tract, suturing of the internal opening, and a water leak test to ensure sealing. In the treatment group, the patients own coagulating blood RD2 Ver.02 will be applied inside the fistula tract to serve as a provisional matrix. In the control group, the blood sample will be discarded, and saline will be applied instead. Treatments are performed in the operating room. Participants will be monitored for healing and complications through 6 to 12 months post-treatment. The primary outcome is the combined healing rate of anal fistulas at 6 months. Secondary outcomes include clinical recurrence at 12 months and incidence of perirectal infections at 6 months. Blood samples, clinical evaluations, and imaging pelvic MRI are used to assess eligibility and monitor safety and efficacy. The trial will continue enrollment and follow-up until June 2028.

A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas