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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

NCT05641844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-11-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • RedDress Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-20
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641844 on ClinicalTrials.gov