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

NCT ID: NCT01624350

Last Updated: 2016-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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

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Anorectal Fistulas

Keywords

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Anorectal Fistulas

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Permacol collagen paste

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pasquale Giordano, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Whipps Cross University Hospital

Locations

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Aalborg Hospital

Aalborg, , Denmark

Site Status

Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Casa di Cura PIO X

Milan, , Italy

Site Status

AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia

Pordenone, , Italy

Site Status

University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata

Rome, , Italy

Site Status

Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Leicester General Hospital

Leicester, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Whipps Cross University Hospital

London, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle, , United Kingdom

Site Status

Countries

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Denmark Italy United Kingdom

Other Identifiers

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COVPERP0200

Identifier Type: -

Identifier Source: org_study_id