Actively Recruiting
A Prospective, Multi-Center, Double Blind, Randomized Controlled Study Evaluating the Safety and Efficacy of RD2 Ver.02 for the Management of Anal Fistulas
Led by RedDress Ltd. · Updated on 2025-11-13
110
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 patient's 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.
CONDITIONS
Brief Title
A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older
- Has a transsphincteric or long intersphincteric anal fistula larger than 1.5 cm with a seton in place for at least 1 month
- Eligible for primary or repeat fistula repair by anorectal advancement flap or LIFT procedure
- Unable or unwilling to receive invasive surgical procedures and opting for minimally invasive fistula management
- Underwent pelvic MRI within 3 months before treatment visit
- Females capable of conceiving and males capable of insemination must use acceptable contraception during the study and for 6 months after
You will not qualify if you...
- Life expectancy less than 24 months
- Cognitive impairment preventing informed consent
- Unable to withdraw required blood volume (up to 15 mL)
- Pregnant or breastfeeding women
- Currently receiving or scheduled for systemic steroids over 10mg per day
- Multiple fistula tracts confirmed by pelvic MRI
- Short fistula tract suitable for fistulotomy
- Active local or systemic infection including perianal infection
- Perirectal abscess present on pelvic MRI
- Active Crohn's disease requiring immediate therapy
- Rectal or anal stenosis or active proctitis limiting surgery
- Allergies to antibiotics, Human Serum Albumin, DMEM, bovine materials, local anesthetics, gadolinium, or RD2 Ver.02 components
- Contraindications to MRI
- Known coagulation problems or abnormal thrombocytes
- Significant lab abnormalities (creatinine, bilirubin, liver enzymes, hemoglobin, platelets, albumin)
- Inability or unwillingness to comply with study procedures
- Recent or current investigational drug use within 12 months
- Need for other perianal surgery within 24 weeks after treatment
- Contraindication to anesthesia
- Diagnosis of Ulcerative Colitis
- Active malignancy under treatment
- Rectovaginal fistula
- History of pelvic radiation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants undergo debridement and suturing of the internal opening of the anal fistula followed by application of RD2 Ver.02 or saline into the fistula tract with a semi flexible cannula in the operating room.
1 visit (in-person, procedure in operating room)
Duration - Up to 12 months after treatment
Participants are monitored for healing and clinical recurrence of the anal fistula, as well as for any infections or complications after the procedure.
Visits at 6 months and 12 months post-treatment
Trial Site Locations
Total: 10 locations
1
Karen Zaghiyan, M.D
Los Angeles, California, United States, 90048
Completed
2
Cleveland Clinic
Weston, Florida, United States, 33331
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Franciscan Health
Indianapolis, Indiana, United States, 46237
Actively Recruiting
5
UMASS
Worcester, Massachusetts, United States, 01605
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
8
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
9
Brown surgical associates
Providence, Rhode Island, United States, 02904
Actively Recruiting
10
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
Research Team
S
Sharon Sirota
A
Alon Kushnir
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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