Gastroenterology
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Clinical Trials
Clinical Trial Number: SP002
| Study ID: | SP002 |
|---|---|
| Phase | N/A |
| Physician Investigator(s) | |
| Study Locations |
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Inclusion Criteria:
- Age 18 - 75 years
- Presence of Single Continuous Anal Fistula presenting for initial curative surgery
- Failed or Recurrent Anal Fistula Closure
- Minimum of 6-weeks of draining seton placed prior to procedure.
- Availability for follow-up contacts and willingness to complete the Informed Consent.
Exclusion Criteria:
- Fistula tract shorter than 2cm
- omplex fistula tract (branching)
- Body Mass Index > 35
- Known uncontrolled diabetes or other systemic condition associated with impaired healing
- Known HIV-positive or immunocompromised
- Rectal prolapse
- Pregnancy
- Rectal / fistula malignancy
- Crohn's disease
- Ulcerative proctitis
- Hidradenitis suppurativa of the anal region
- Pilonidal sinus disease
- Presence of hemorrhoid Involving fistula site
- Continuous use of anti-inflammatory
- Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
- Active infection or abscess involving fistula site
- Known allergy to PLGA material
- Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
- Treatment with an investigational drug or medical device in the past 30 days