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

NCT05641844 | Recruiting FDA Device

• 1 other identifier: RD014
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control

  Fistula healing will be assessed by both a blinded clinical assessor and confirmation by MRI. Healing clinical assessment is defined as the absence of any anal symptom, with no discharge from the fistula and a closed external opening. Results will be confirmed by central blinded MRI assessment.

  6 months after anal fistula treatment per subject

Secondary Outcomes (2)

• Clinical recurrence of anal fistula at 12 months post-treatment in subjects with clinically healed fistula at 6 months, treated with RD2 Ver. 02 compared to control, to evaluate the long-term efficacy of RD2 Ver.02 Application.

  12 months

• Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control.

  6 months

Other Outcomes (2)

• Incidence of device-related adverse events in patients treated with RD2 Ver.02

  12 months

• Incidence of adverse events compared between RD2 Ver.02 and control arms

  12 months

Study Arms (2)

Treatment arm

OTHER

Subjects will undergo debridement of the fistula tract and suturing of internal opening, followed by a. water leak test. RD2 Ver.02 will be applied to the fistula tract in the operating room.

Device: RD2 Ver.02; Other: Saline

Control arm

OTHER

Subjects will undergo debridement of the fistula tract and suturing of internal opening, followed by a. water leak test. Saline will be applied to the fistula tract in the operating room.

Other: Saline

Interventions

RD2 Ver.02 DEVICE

Debridement and suturing of the internal opening of the anal fistula and RD2 Ver.02 coagulating blood application into the fistula tract with a semi flexible cannula.

Treatment arm

Saline OTHER

Debridement and suturing of the internal opening of the anal fistula and Saline administration into the fistula tract with a semi flexible cannula.

Control arm; Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age
• Subject has a transsphincteric or long intersphincteric anal fistula (\>1.5 cm), with a seton in place for a minimum of 1 month, deemed eligible for primary or repeat fistula repair by anorectal advancement flap or LIFT: Anterior, posterior or lateral fistula, first or recurrent, at any position circumferentially, with one external opening and one internal opening.
• Subjects is unable or unwilling to receive invasive surgical procedures, anorectal advancement flap or LIFT procedure, and is opting for minimally invasive technique of anal fistula management (i.e., fistula tract debridement and suturing of internal opening).
• Prior to enrollment, during the preceding 3 months from Treatment Visit, subject must undergo a pelvic MRI to evaluate eligibility criteria unable to be assessed clinically.
• Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study and for 6 months following study procedure (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women)

You may not qualify if:

• Subject who has a life expectancy of less than 24 months.
• Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.
• Cannot withdraw blood in the required amount (up to 15 mL).
• Women who are pregnant or currently breast feeding.
• Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (more than 10mg per day).
• Multiple fistula tracts, as confirmed on pelvic MRI
• Short fistula tract that in the surgeon's opinion are amenable to fistulotomy
• Active infection including perianal infection, and/or any active systemic or local infection.
• Presence of a perirectal abscess on pelvic MRI
• Presence of dominant luminal active Crohn's disease, validated by recent colonoscopy from preceding 12 months, requiring immediate therapy
• Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.
• Known allergies or hypersensitivity to any of the following: antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; Human Serum Albumin (HSA); Dulbecco Modified Eagle's Medium (DMEM); materials of bovine origin; local anaesthetics or gadolinium (MRI contrast); Known hypersensitivity to reagents and components of RD2 Ver.02 including calcium gluconate, Kaolin or citrate and ethylene oxide.
• Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements, or severe claustrophobia).
• Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking Coumadin, Aspirin, Plavix (Clopidogrel), Eliquis or Pradaxa will not be excluded.
• Patients with increased risk for the surgical procedure or major alteration of any of the following laboratory tests:

Sponsors & Collaborators

• RedDress Ltd.: lead

Study Sites (10)

Karen Zaghiyan, M.D

Los Angeles, California, 90048, United States

COMPLETED

Cleveland Clinic

Weston, Florida, 33331, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Franciscan Health

Indianapolis, Indiana, 46237, United States

RECRUITING

UMASS

Worcester, Massachusetts, 01605, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Brown surgical associates

Providence, Rhode Island, 02904, United States

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Sharon Sirota

CONTACT

+972-54-580-0765; sharon@reddress.co.il

Alon Kushnir

CONTACT

+972-50-630-6312; alon@reddress.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: January 20, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (9); IL (1)