CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Permacol collagen pastedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01624350
NCT01624350N/ACompleted
CompareCT.gov

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

Medtronic - MITG·observational·Posted Jun 20, 2012·Updated Nov 30, 2016

In Brief

An observational study evaluating Permacol collagen paste for Anorectal Fistulas. Completed, enrolled 100 participants across 10 sites in 3 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAnorectal Fistulas
CountriesDenmark, Italy, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2012
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.0 years ago

Interventions

Permacol collagen pastedevice

Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.