Is NCT05641844 recruiting in Providence, RI?

Yes, NCT05641844 is currently recruiting participants at its Providence, RI location. This anal fistula clinical trial is actively enrolling qualified participants.

How do I join the anal fistula clinical trial in Providence?

To join this clinical trial in Providence, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Providence clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anal Fistula Clinical Trial in Providence, RI

About This Anal Fistula Study in Providence

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.

Sponsor: RedDress Ltd.

Who Can Participate

Inclusion Criteria

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).

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.

Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study and for 6 months following study procedure (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women)

Exclusion Criteria

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.

Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (more than 10mg per day).

Multiple fistula tracts, as confirmed on pelvic MRI

Short fistula tract that in the surgeon's opinion are amenable to fistulotomy

Active infection including perianal infection, and/or any active systemic or local infection.

Presence of a perirectal abscess on pelvic MRI

Presence of dominant luminal active Crohn's disease, validated by recent colonoscopy from preceding 12 months, requiring immediate therapy

Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.

Known allergies or hypersensitivity to any of the following: antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; Human Serum Albumin (HSA); Dulbecco Modified Eagle's Medium (DMEM); materials of bovine origin; local anaesthetics or gadolinium (MRI contrast); Known hypersensitivity to reagents and components of RD2 Ver.02 including calcium gluconate, Kaolin or citrate and ethylene oxide.

Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements, or severe claustrophobia).

Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking Coumadin, Aspirin, Plavix (Clopidogrel), Eliquis or Pradaxa will not be excluded.

Patients with increased risk for the surgical procedure or major alteration of any of the following laboratory tests:

Serum Creatinine levels \>1.5 times the upper limit of normality (ULN)

Total bilirubin \>1.5 times the ULN (unless predominantly non conjugated due to documented history of Gilbert's syndrome)

AST/ ALT \>3.0 times the ULN

Hemoglobin \<10.0 g/dL

Platelets \<150.0 x109/L

Albuminemia \<3.0 g/dL.

Patients who do not wish to or cannot comply with study procedures.

Patients currently receiving or having received within 12 months prior to enrolment into this clinical study, any investigational drug.

Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.

Contraindication to the anesthetic procedure.

Subject with a diagnosis of Ulcerative Colitis

Subject with malignancy, undergoing active treatment

Rectovaginal fistula

History of pelvic radiation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Providence?

Yes, this clinical trial (NCT05641844) has an active research site in Providence, RI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anal Fistula Treatment Options in Providence, RI

If you're searching for anal fistula treatment options in Providence, RI, this clinical trial (NCT05641844) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Providence research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anal fistula specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Anal Fistula Clinical Trial in Providence, RI

Expert Care in Providence

IRB Approved

No-Cost Care

Apply for This Providence Location

Why Participate?

Simple Process