Anorectal Fistulas Clinical Trial
Official title:
MASERATI 100 - A Prospective, Multi-center, Post-mArket, Single-arm obsERvATIonal Study to Collect Clinical Outcome Data on the Use of Permacol™ Collagen Paste in the Treatment of Anorectal Fistulas
This will be a prospective, multi-center, post-market, single arm observational study to
collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of
anorectal fistulas.
The subjects will have baseline and day of surgery visits performed, and then subjects will
return to the investigator for evaluation of defect and safety related morbidities at follow
up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.
The study will enroll 100 subjects at up to 10 centers throughout the European Union. The expected duration of the enrollment period is approximately 9 months. The duration of each subject's participation in the study will be approximately one year. However, at sites where the routine follow-up period is greater than one year, subjects may be followed for up to 36 months at their surgeon's discretion if they agree to it. ;
Time Perspective: Prospective