Veritas in Non-Bridging Ventral Hernia Repair

NCT ID: NCT01426477

Last Updated: 2018-01-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-08-31

Brief Summary

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The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.

Detailed Description

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Conditions

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Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Veritas Collagen Matrix

Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years of age or older
* Ability to understand and read English
* Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
* Must be of ambulatory status
* Primary closure can be obtained during surgery
* Repair is such that one piece of Veritas can be used to reinforce the repair

Exclusion Criteria

* Hernia is undetectable on physical exam
* There is evidence of existing cancer
* BMI ≥ 40
* Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
* Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synovis Surgical Innovations

INDUSTRY

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic Department of Surgery

Jacksonville, Florida, United States

Site Status

Watson Clinic Center for Research

Lakeland, Florida, United States

Site Status

Atlanta Colon & Rectal Surgery, P.A.

Atlanta, Georgia, United States

Site Status

Pratt Medical Center

Fredericksburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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09-004

Identifier Type: -

Identifier Source: org_study_id

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