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Trial record 1 of 1 for:    NCT05641844
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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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ClinicalTrials.gov Identifier: NCT05641844
Recruitment Status : Not yet recruiting
First Posted : December 8, 2022
Last Update Posted : December 11, 2023
Sponsor:
Information provided by (Responsible Party):
RedDress Ltd.

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.


Condition or disease Intervention/treatment Phase
Anal Fistula Device: RD2 Ver.02 Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : January 20, 2024
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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.
Device: 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.

Other: Saline
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
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
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 Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Recurrence of anal fistula at 12 months post-treatment in subjects with healed fistula treated with RD2 Ver.02 compared to control, to evaluate the long-term efficacy of RD2 Ver.02 Application. [ Time Frame: 12 months ]
    Assessed by the blinded clinical assessor for fistula recurrence 12 months post procedure

  2. Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. [ Time Frame: 6 months ]
    Infection assessment of the anal fistula


Other Outcome Measures:
  1. Incidence of device-related adverse events in patients treated with RD2 Ver.02 [ Time Frame: 12 months ]
    Overall incidence and severity of Adverse Events (AEs) in RD2 Ver.02 treatment group

  2. Incidence of adverse events compared between RD2 Ver.02 and control arms [ Time Frame: 12 months ]
    Comparison of the AEs between RD2 Ver.02 and control treatment groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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)

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:

Serum Creatinine levels >1.5 upper limit of normality (ULN) Total bilirubin >1.5 ULN (unless predominantly non conjugated due to documented history of Gilbert's syndrome) AST/ ALT >3.0 ULN Hemoglobin <10.0 g/dL Platelets <150.0 x109/L 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641844


Contacts
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Contact: Sharon Sirota +972-54-580-0765 sharon@reddress.co.il
Contact: Alon Kushnir +972-50-630-6312 alon@reddress.co.il

Locations
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United States, Florida
Cleveland Clinic
Weston, Florida, United States, 33331
Contact: Cecilia Calvo       CALVOC@ccf.org   
Principal Investigator: Giovanna Da Silva Southwick, MD         
Sponsors and Collaborators
RedDress Ltd.
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Responsible Party: RedDress Ltd.
ClinicalTrials.gov Identifier: NCT05641844    
Other Study ID Numbers: RD014
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: December 11, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases