RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-20

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05641844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, involving \>20% of anal sphincter. * 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 subject must undergo a pelvic MRI to document intersphincteric or transsphicnteric fistula and absence of underlying abscess * 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)	* 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: * 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

Inclusion Criteria

Exclusion 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, involving \>20% of anal sphincter.
* 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 subject must undergo a pelvic MRI to document intersphincteric or transsphicnteric fistula and absence of underlying abscess
* 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)

* 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:
* 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

Contacts and Locations

Study Contact

Sharon Sirota

CONTACT

+972-54-580-0765

sharon@reddress.co.il

Alon Kushnir

CONTACT

+972-50-630-6312

alon@reddress.co.il

Study Locations (Sites)

Karen Zaghiyan, M.D

Los Angeles, California, 90048

United States

Cleveland Clinic

Weston, Florida, 33331

United States

University of Chicago

Chicago, Illinois, 60637

United States

Franciscan Health

Indianapolis, Indiana, 46237

United States

UMAS

Worcester, Massachusetts, 01605

United States

Lenox Hill Hospital

New York, New York, 10075

United States

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212

United States

Brown surgical associates

Providence, Rhode Island, 02904

United States

Collaborators and Investigators

Sponsor: RedDress Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-20

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-01-20

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Anal Fistula