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Tests treatment safety and results for Anal Fistula
Official title A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
ClinicalTrials.gov ID: NCT05641844
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- people is unable or unwilling to receive invasive surgical procedures, anorectal advancement flap or LIFT procedure, and is opting for minimally...
- 2.1.4 Prior to enrollment, during the preceding 3 months from Treatment Visit, subject must undergo a pelvic MRI to evaluate eligibility criteria...
- Female people who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to...
You likely can't join if
- Subject who has a life expectancy of less than 24 months.
- people who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of...
- 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
See the full eligibility 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...
- people 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...
- 2.1.4 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 people 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...
- Subject who has a life expectancy of less than 24 months.
- people 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...
- 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. people 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.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Weston, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Worcester, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Ramat Gan, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Weston, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; Worcester, Massachusetts, United States; Rochester, Minnesota, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.