Recruiting

RD2 Ver.02

Sponsor:

RedDress Ltd.

Code:

NCT05641844

Conditions

Anal Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RD2 Ver.02

Saline

Study Details

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

Study ID

NCT05641844

Start date

Jan 20, 2024

Status verified date

Nov, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).
  • 2.1.4 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)

Exclusion Criteria:

  • 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:

1. Serum Creatinine levels >1.5 times the upper limit of normality (ULN)
2. Total bilirubin >1.5 times the ULN (unless predominantly non conjugated due to documented history of Gilbert's syndrome)
3. AST/ ALT >3.0 times the ULN
4. Hemoglobin <10.0 g/dL
5. Platelets <150.0 x109/L
6. Albuminemia <3.0 g/dL.
  • Patients who do not wish to or cannot comply with study procedures.
  • Patients currently receiving or having received within 12 months prior to enrolment into this clinical study, any investigational drug.
  • Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.
  • Contraindication to the anesthetic procedure.
  • Subject with a diagnosis of Ulcerative Colitis
  • Subject with malignancy, undergoing active treatment
  • Rectovaginal fistula
  • History of pelvic radiation

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Treatment arm

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.

other: Control arm

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.

Interventions

RD2 Ver.02

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.

Saline

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

Primary outcome measure

  • Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control [ Time Frame: 6 months after anal fistula treatment per subject ]

Central Contacts and Locations

Central contacts

Sharon Sirota

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

Alon Kushnir

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

Locations

Cleveland Clinic

Recruiting

Weston, Florida, United States, 33331

Contacts

Cecilia Calvo

CALVOC@ccf.org

Principal Investigator:

Giovanna Da Silva Southwick, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Guadalupe Castro

Guadalupe.Castro@bsd.uchicago.edu

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

UMASS

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Rafael Fernandes

rafael.fernandes@umassmed.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Summer Auerbach

Auerbach.Summer@mayo.edu

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Sasha Suarez, MD

ssuarez3@northwell.edu

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Rachel Reading

rachel.reading@ahn.org

Brown surgical associates

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Melanie Salerno

melanie.salerno@brownphysicians.org

More Information

Sponsor

RedDress Ltd.

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by RedDress Ltd. on 2025-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.