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New treatment option for Anal Fistula
Official title Tissue Therapy of Transsphincteric Anal Fistula
ClinicalTrials.gov ID: NCT06303752
What this study is testing
What is ADRC injection?
ADRC injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for anal fistula.
Also referred to as Liposuction, Surgical debridement of fistula tract and closure of internal orifice.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
- Phase 2: a mid-size study of how well it works
- 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
- Inclusion criterion: Adult patients (\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30%...
- able to communicate with Danish language
- able to provide informed consent
- having address in the region of southern Denmark during the study
You likely can't join if
- Signs of suppuration/cavitation around the fistula
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
- Immunosuppression (due to clinical condition or medical therapy)
See the full eligibility criteria
- Inclusion criterion: Adult patients (\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense...
- able to communicate with Danish language
- able to provide informed consent
- having address in the region of southern Denmark during the study
- Signs of suppuration/cavitation around the fistula
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
- Immunosuppression (due to clinical condition or medical therapy)
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
- Allergy against the antibiotics: Penicillin and streptomycin.
- Coagulopathy
- Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
- Verified syphilis, HIV, or hepatitis on screening test
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
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 Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.