A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation

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

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.

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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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XenMatrix

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Be able to undergo study procedures.
* Have signed an Informed Consent form (ICF).
* Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
* Requires a component separation repair with the use of a biological graft.

Exclusion Criteria

* Subject is participating in another device or drug study.
* Subject has a life expectancy less than 4 years at the time of enrollment.
* Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
* Any subject with a defect the surgeon feels he/she cannot fully close.
* Subjects with a BMI \> 50.
* Subjects with connective tissue disorders.
* Subjects with a history of cirrhosis.
* Subjects with renal failure requiring dialysis.
* Subjects on or suspected to be placed on chemotherapy or systemic immunosuppressive medications during any part of the study.
* Transplant recipients.
* Subjects taking corticosteroids for \>6 months (pre or post surgery).
* Any bowel leak or infection that would preclude the use of the XenMatrix™ Surgical Graft in the opinion of the investigator.
* The subject lives approximately 2 hours away from the study site and compliance with follow up requirements will be difficult in the opinion of the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No