Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2019-02-07
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perianal Crohn's Disease
Permacol Paste injection
Permacol Paste
Permacol Paste Injection
Interventions
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Permacol Paste
Permacol Paste Injection
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
* Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
* Non-active or mildly active luminal CD defined by a CDAI \< 220
Exclusion Criteria
* Dominant luminal active CD requiring immediate surgical or medical therapy
* Fistula with \> 3 external openings and \> 2 internal openings
* Severe active proctitis and/or rectal stenosis
* Abscess or pelvic collection \> 2 cm diameter
* Concomitant rectovaginal fistulas
* Concomitant steroid treatment or treated with steroids in the last 4 weeks
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Antonino Spinelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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La Raja C, Maroli A, Foppa C, Gabbiadini R, Dal Buono A, Armuzzi A, Carvello M, Spinelli A. Collagen Paste Injection in Crohn's Disease Perianal Fistula: Long-term Outcomes of a Pilot, Prospective Cohort Study. J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024.
Other Identifiers
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2134
Identifier Type: -
Identifier Source: org_study_id
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