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

November 29, 2016 updated by: Medtronic - MITG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
      • Aarhus C, Denmark
        • Aarhus University Hospital
  • Italy
      • Milan, Italy
        • Casa di Cura PIO X
      • Pordenone, Italy
        • AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia
      • Rome, Italy
        • University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata
  • United Kingdom
      • Dundee, United Kingdom
        • Ninewells Hospital & Medical School
      • Leicester, United Kingdom
        • Leicester General Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Whipps Cross University Hospital
      • New Castle, United Kingdom
        • Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects who meet the eligibility criteria that are planned to undergo surgical treatment for anorectal fistulas with Permacol™ Collagen Paste and agree to 12 months of follow-up.

Description

Key Inclusion Criteria:

  1. Male or female subjects age 18 or older
  2. Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin

Key Exclusion Criteria:

  1. History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)
  2. Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas
  3. Indication of an actively infected fistula/abscess (acute sepsis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula Healing in Patients at 6 Months Following Surgery
Time Frame: 6 months
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula Healing in Patients at 3 and 12 Months Following Surgery
Time Frame: 3 months and 12 months
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
3 months and 12 months
Participant Response to Quality of Life EQ-5D Questionnaire
Time Frame: Baseline, and 3 months, 6 months and 12 months post op
Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Baseline, and 3 months, 6 months and 12 months post op
Fecal Incontinence
Time Frame: 3 months, 6 months and 12 months
Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.
3 months, 6 months and 12 months
Patient Satisfaction Between the First and Last Post-operative Visit
Time Frame: Between the first and last visits
Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.
Between the first and last visits
Pain
Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months
Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.
Baseline, 1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Pasquale Giordano, MD, FRCS, Whipps Cross University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVPERP0200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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