NCT01624350

A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anorectal Fistulas

Interventions

Type	Name	Description
DEVICE	Permacol collagen paste	Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2012-06-20
• Last updated: 2016-11-30
• Results posted: 2016-11-30

Locations

10 sites across 3 countries: Denmark, Italy, United Kingdom