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.
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.
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.
Parallel
RD2 Ver.02
DeviceDebridement 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
Other interventionDebridement and suturing of the internal opening of the anal fistula and Saline administration into the fistula tract with a semi flexible cannula.
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.
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.
Assessed by the blinded clinical assessor for fistula recurrence 12 months post procedure
Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control.
Infection assessment of the anal fistula
Incidence of device-related adverse events in patients treated with RD2 Ver.02
Overall incidence and severity of Adverse Events (AEs) in RD2 Ver.02 treatment group
Incidence of adverse events compared between RD2 Ver.02 and control arms
Comparison of the AEs between RD2 Ver.02 and control treatment groups
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