Anal FistulaNCT05641844
A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
A study testing RD2 Ver.02 and Saline in people with Anal Fistula, run by RedDress Ltd. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- RD2 Ver.02 and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 Jan 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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 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)
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 8 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Guadalupe Castro, Guadalupe.Castro@bsd.uchicago.edu
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
Emily Crawford
- Completed
Karen Zaghiyan, M.D
Los Angeles, California, 90048
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Sasha Suarez, MD, ssuarez3@northwell.edu
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Rachel Reading, rachel.reading@ahn.org
- Recruiting
Brown surgical associates
Providence, Rhode Island, 02904
Melanie Salerno, melanie.salerno@brownphysicians.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Summer Auerbach, Auerbach.Summer@mayo.edu
- Recruiting
Cleveland Clinic
Weston, Florida, 33331
Cecilia Calvo, CALVOC@ccf.org
Giovanna Da Silva Southwick, MD
- Recruiting
UMASS
Worcester, Massachusetts, 01605
Rafael Fernandes, rafael.fernandes@umassmed.edu
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Ilan Kent, MD
About this study
Official title: A Prospective, Multi-Center, 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:
Read more
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
- Anal Fistula
- Being tested
- RD2 Ver.02, Saline
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD2 Ver.02Device
Debridement and suturing of the internal opening of the anal fistula and RD2 Ver.02 coagulating blood application into the fistula tract with a semi flexible cannula.
SalineOther
Debridement and suturing of the internal opening of the anal fistula and Saline administration into the fistula tract with a semi flexible cannula.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Other | 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. Receives: Device: RD2 Ver.02; Other: Saline |
| Control arm | Other | 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control
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.
Measured: 6 months after anal fistula treatment per subject
Secondary outcomes (2)
Clinical recurrence of anal fistula at 12 months post-treatment in subjects with clinically healed fistula at 6 months, treated with RD2 Ver. 02 compared to control, to evaluate the long-term efficacy of RD2 Ver.02 Application.
Assessed by the blinded clinical assessor for fistula recurrence 12 months post procedure
Measured: 12 months
Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control.
Infection assessment of the anal fistula
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start20 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641844
- Sponsor's protocol ID
- RD014
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02, For the Management of Anal Fistulas
- ClinicalTrials.gov ID
- NCT05641844
- Acronym / sponsor ID
- RD014
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Other | Device: RD2 Ver.02, Other: SalineSubjects 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. |
| Control arm | Other | Other: SalineSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- 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 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)
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD2 Ver.02Debridement and suturing of the internal opening of the anal fistula and RD2 Ver.02 coagulating blood application into the fistula tract with a semi flexible cannula. | Device | Treatment arm |
| SalineDebridement and suturing of the internal opening of the anal fistula and Saline administration into the fistula tract with a semi flexible cannula. | Other | Control arm, Treatment arm |
Primary outcome
Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control
Time frame: 6 months after anal fistula treatment per subject
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.
2 secondary outcomes
Clinical recurrence of anal fistula at 12 months post-treatment in subjects with clinically healed fistula at 6 months, treated with RD2 Ver. 02 compared to control, to evaluate the long-term efficacy of RD2 Ver.02 Application.
Time frame: 12 months
Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
Related trials for Anal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
Not yet recruitingPhase 4
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
Perianal Abscess, Anal Fistula
Not yet recruitingObservational study
Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula
Complex Anal Fistula, Cryptoglandular Anal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD2 Ver.02 and Saline in people with Anal Fistula, run by RedDress Ltd. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Sirota (+972-54-580-0765, sharon@reddress.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined healing rate at 6 months of anal fistulas treated with RD2 Ver.02 compared to control (time frame: 6 months after anal fistula treatment per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.