Description
Seeking men and women who need surgical treatment for a fistula-in-ano for a study of an investigational surgical device. A fistula-in-ano is an abnormal connection between your anal canal and the skin near the anus which may cause fecal incontinence.
Overview
Study participants will have a screening office visit where they will have pre-operative testing, complete a survey to assess their level of fecal incontinence, if any, and consent for the CO2 laser technology procedure. Following the surgery, there will be 5 follow-up office visits over a year that will include a physical exam and review of medical history.
What we're hoping for
To evaluate whether the use of an investigational surgical technology to ablate a fistula-in-ano tract work as well as other more invasive surgical interventions that are the current standard for treatment.
Additional Information
ClinicalTrials.gov Identifier: Not Available