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NCT05641844 · ClinicalTrials.gov registry record · NA
A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
A NA study of Anal Fistula, sponsored by RedDress.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 10
- Study locations
NCT05641844: Recruiting NA study of Anal Fistula, sponsored by RedDress.
NCT05641844 is a NA study of Anal Fistula that is actively recruiting participants, run by RedDress. The registered enrollment target is 110 participants, below the 280-participant average among 5 other Anal Fistula trials with a reported enrollment target (61% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05641844, a NA study of Anal Fistula, is actively recruiting participants, sponsored by RedDress.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Saline
- DEVICE RD2 Ver.02
Study Locations (10)
California
- Karen Zaghiyan, M.D - Los Angeles
Florida
- Cleveland Clinic - Weston
Illinois
- University of Chicago - Chicago
Indiana
- Franciscan Health - Indianapolis
Massachusetts
- UMASS - Worcester
Minnesota
- Mayo Clinic - Rochester
New York
- Lenox Hill Hospital - New York
Pennsylvania
- Allegheny Health Network - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-01-20 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
What NCT05641844 shows while recruiting
NCT05641844 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 280-participant average among 5 other Anal Fistula trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Anal Fistula appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT05641844 lists 10 locations in 10 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT05641844 about?
NCT05641844 is a clinical study titled "A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas". 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...
What is the current status of trial NCT05641844?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2024-01-20. Estimated completion is 2028-06-30.
What conditions does trial NCT05641844 study?
This clinical trial studies the following conditions: Anal Fistula.
What interventions are being tested in trial NCT05641844?
The interventions under investigation include: Saline (OTHER), RD2 Ver.02 (DEVICE).
Who is sponsoring clinical trial NCT05641844?
This trial is sponsored by RedDress, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05641844 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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