Actively Recruiting
A 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
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.
CONDITIONS
Official 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
- Subject has a transsphincteric or long intersphincteric anal fistula (>1.5 cm) with a seton in place for at least 1 month
- Fistula is suitable for primary or repeat repair by anorectal advancement flap or LIFT procedure
- Subject is unable or unwilling to receive invasive surgical procedures and opts for minimally invasive fistula management
- Subject must have pelvic MRI within 3 months before treatment visit
- Female subjects capable of conceiving and males capable of insemination must use contraception during the study and for 6 months after
You will not qualify if you...
- Life expectancy less than 24 months
- Cognitive impairment preventing understanding of consent
- Unable to withdraw required blood amount (up to 15 mL)
- Pregnant or breastfeeding women
- Receiving or scheduled to receive systemic steroids over 10 mg per day within past 30 days
- Multiple fistula tracts confirmed by MRI
- Short fistula tract suitable for fistulotomy
- Active perianal or systemic infection
- Presence of perirectal abscess on MRI
- Active luminal 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
- Contraindication to MRI (e.g., pacemakers, hip replacements, severe claustrophobia)
- Known coagulation problems or abnormal platelet levels
- Major abnormal laboratory test results (e.g., elevated creatinine, bilirubin, liver enzymes; low hemoglobin, platelets, albumin)
- Inability or unwillingness to comply with study procedures
- Received investigational drugs within 12 months prior to enrollment
- Need for perianal surgery unrelated to fistulas during study period
- Contraindication to anesthesia
- Diagnosis of Ulcerative Colitis
- Active malignancy treatment
- Rectovaginal fistula
- History of pelvic radiation
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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
CONTACT
A
Alon Kushnir
CONTACT
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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