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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01624350
First received: June 15, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition
Anorectal Fistulas

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Fistula healing at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical assessment of fistula healing


Secondary Outcome Measures:
  • Fistula healing/recurrence [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Fistula healing/recurrence by clinical assessment

  • Quality of Life [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Quality of Life by EQ-5D questionnaire

  • Fecal Incontinence [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Fecal Incontinence by CCF-FI questionnaire

  • Patient Satisfaction [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Patient satisfaction questionnaire

  • Pain [ Time Frame: 1 month, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Pain by VAS


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624350

Locations
Denmark
Aalborg Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus C, Denmark
Italy
Casa di Cura PIO X
Milan, Italy
AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia
Pordenone, Italy
University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata
Rome, Italy
United Kingdom
Ninewells Hospital & Medical School
Dundee, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
King's College Hospital
London, United Kingdom
Whipps Cross University Hospital
London, United Kingdom
Royal Victoria Infirmary
New Castle, United Kingdom
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Pasquale Giordano, MD, FRCS Whipps Cross University Hospital
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01624350     History of Changes
Other Study ID Numbers: COVPERP0200
Study First Received: June 15, 2012
Last Updated: February 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee
Denmark: Ethics Committee

Keywords provided by Covidien:
Anorectal Fistulas

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Digestive System Diseases
Digestive System Fistula
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Fistula
Pathological Conditions, Anatomical
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014