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RECRUITING NA

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

NCT05641844 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 110 participants
Start Date 2024-01-20
Est. Completion 2028-06-30
Phase NA

Sponsor

RedDress

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05641844

The ClinicalTrials.gov registry entry for NCT05641844 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RedDress, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05641844 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05641844?

The interventions under investigation include: Saline (OTHER), RD2 Ver.02 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05641844?

This trial is sponsored by RedDress, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial