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

C. R. Bard

Status: Terminated

Conditions: Hernia

Study type: Observational

Funder types: Industry

Identifiers

NCT01305486

DVL-HE008

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4 participants in 1 patient group

XenMatrix