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Autologous Blood Product

Treatment arm for Anal Fistulas

N/A

Recruiting

Research Sponsored by RedDress Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will assess how safe and effective a new anal fistula treatment is, and compare it to a control treatment.

Who is the study for?

This trial is for adults over 18 with a specific type of anal fistula, who have had a seton in place for at least one month. They should not be candidates for or willing to undergo invasive surgical procedures and must have confirmed their condition with an MRI. Participants must use contraception if they can conceive.Check my eligibility

What is being tested?

The study tests RD2 Ver.02, using the patient's own blood to create a clot as treatment, against saline application in managing anal fistulas. It's randomized and double-blind, meaning neither patients nor doctors know who gets which treatment until after the results are collected.See study design

What are the potential side effects?

While specific side effects aren't listed here, common concerns may include infection risk around the treated area, potential recurrence of the fistula, or complications from the procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a long anal fistula and have had a seton for over a month.

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I prefer minimally invasive treatment for my anal fistula over surgery.

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I had a pelvic MRI in the last 3 months showing a specific type of fistula without an abscess.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control

Secondary outcome measures

Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control.

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.

Other outcome measures

Incidence of adverse events compared between RD2 Ver.02 and control arms

Incidence of device-related adverse events in patients treated with RD2 Ver.02

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment armExperimental Treatment2 Interventions

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.

Group II: Control armExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

RedDress Ltd.Lead Sponsor

6 Previous Clinical Trials

702 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots available in this research experiment?

"Clinicaltrials.gov confirms that this trial, initially posted on the 20th of January 2024 and last modified on the 4th of December 2023 is not actively recruiting at present; however there are 114 other studies with open enrollment currently available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05641844.

All > Anal Fistula