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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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2023-11-15
2027-12-31
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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Fortiva Tissue Matrix
Fortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery
Interventions
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Fortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery
Eligibility Criteria
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Inclusion Criteria
* Undergoing hernia surgery in which Fortiva Tissue Matrix will be used
* Have no contraindications to the test material (s)
* Able to provide informed consent
* Able to read, understand and complete study questionnaires
* Able and willing to return for scheduled study visits
Exclusion Criteria
* American Society of Anesthesiologists (ASA) physical class of 4,5 or 6
* Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
* Hernia repairs involving active infection
18 Years
ALL
No
Sponsors
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RTI Surgical
INDUSTRY
Responsible Party
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Locations
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James Paget University Hospital
Great Yarmouth, , United Kingdom
Countries
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Other Identifiers
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RTI-2022-01
Identifier Type: -
Identifier Source: org_study_id
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