The purpose of this study is to determine whether treatment with laser coagulation is an
effective and safe treatment option for patients with anal fistula
Procedure: Laser Coagulation
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Full eligibility criteria for NCT03017898
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Subject must be at least 18 years of age
Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
Subject must be able to comply with study and study follow-up requirements.
Subject with anorectal fistula due to Crohn's disease
Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
Subject has fistula with side tracts (as seen on transanal ultrasound)
Subject is unable or unwilling to provide informed consent.
All locations for NCT03017898
Skåne University Hospital
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Tris trial is registered with FDA with number: NCT03017898. The sponsor of the trial is Region Skane and it is looking for 52 volunteers for the current phase.
Official trial title: Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
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