A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
This study is currently recruiting participants.
Verified February 2013 by Covidien
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01624350
First received: June 15, 2012
Last updated: February 19, 2013
Last verified: February 2013
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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: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
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:
- Male or female subjects age 18 or older
- Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin
Key Exclusion Criteria:
- History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)
- Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas
- Indication of an actively infected fistula/abscess (acute sepsis)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624350
Contacts
| Contact: Brendan M Slagle, BS | 01 781 577 5817 | brendan.slagle@covidien.com |
| Contact: Kristina Man | 01 781 577 5824 | kristina.man@covidien.com |
Locations
| Denmark | |
| Aalborg Hospital | Recruiting |
| Aalborg, Denmark | |
| Contact: Ole Thorlacius-Ussing +45 99 32 25 25 | |
| Principal Investigator: Ole Thorlacius-Ussing, MD | |
| Aarhus University Hospital | Recruiting |
| Aarhus C, Denmark | |
| Contact: Steen Buntzen +458 617-5494 | |
| Principal Investigator: Steen Buntzen, MD | |
| Italy | |
| Casa di Cura PIO X | Recruiting |
| Milan, Italy | |
| Contact: Leonardo Lenisa +39 02 69517463 | |
| Principal Investigator: Leonardo Lenisa, MD | |
| AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia | Recruiting |
| Pordenone, Italy | |
| Contact: Angelo Stuto +39 0434 399306 | |
| Principal Investigator: Angelo Stuto, MD | |
| University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata | Recruiting |
| Rome, Italy | |
| Contact: Pierpaolo Sileri +39 333 9137249 | |
| Principal Investigator: Pierpaolo Sileri, MD | |
| United Kingdom | |
| Ninewells Hospital & Medical School | Recruiting |
| Dundee, United Kingdom | |
| Contact: Dorin Ziyaie +01382-660111 | |
| Principal Investigator: Dorin Ziyaie, MD | |
| Leicester General Hospital | Recruiting |
| Leicester, United Kingdom | |
| Contact: Baljit Singh +44 116 258 8252 | |
| Principal Investigator: Baljit Singh, MD | |
| King's College Hospital | Recruiting |
| London, United Kingdom | |
| Contact: Joseph Nunoo-Mensah +44 020 3299 3869 | |
| Principal Investigator: Joseph Nunoo-Mensah, MD | |
| Whipps Cross University Hospital | Recruiting |
| London, United Kingdom | |
| Contact: Giordano Giordano +0044(0)20 8535 6656 | |
| Principal Investigator: Pasquale Giordano, MD, FRCS | |
| Royal Victoria Infirmary | Recruiting |
| New Castle, United Kingdom | |
| Contact: Ben Griffiths +0191 2820070 | |
| Principal Investigator: Ben Griffiths, MD | |
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 19, 2013 |
| 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 Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013