Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias

C

C. R. Bard

Status

Completed

Conditions

Incisional Hernia

Treatments

Device: Xen Matrix AB

Study type

Interventional

Funder types

Industry

Identifiers

NCT02691962
DVL-HE-012

Details and patient eligibility

About

This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.

Full description

This is a post-market, on-label study to understand the performance of the graft in the US.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject must be willing and able to give written informed consent.
  • Subject must be diagnosed with a ventral or incisional midline hernia.
  • Mesh must be placed in the retro-rectus or intraperitoneal plane.
  • Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion criteria

  • The use of surgical graft as a bridge repair.
  • The subject has more than 4 prior recurrences.
  • Subject has a contraindication for the placement of surgical graft.
  • Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
  • The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides).
  • Subject has intact permanent mesh adjacent to the current hernia to be repaired.
  • Subject has peritonitis at the time of surgery.
  • The subject is an active smoker within the last 2 weeks prior to surgery.
  • Clinically significant Chronic Obstructive Pulmonary Disease or heart failure, defined as marked limitation in ability or inability to perform activities of daily living.
  • Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study.
  • Chronic steroid use (>6 months) or immunosuppression drugs.
  • Subject's body mass index (BMI) >45 kg/m2.
  • Subject has cirrhosis, and/or ascites.
  • Subject has a defined collagen disorder.
  • Known to be infected with human immunodeficiency virus (HIV).
  • Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits Activities of Daily Living, is on hemodialysis or peritoneal dialysis.
  • Subject is American Society of Anesthesiology (ASA) Class 4 or 5.
  • Subject has a life expectancy < 2 years at the time of enrollment.
  • Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study.
  • Subjects with known sensitivity to porcine products.
  • Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin).
  • Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

Xen Matrix AB
Experimental group
Description:
Subjects treated with Xen Matrix AB
Treatment:
Device: Xen Matrix AB

Trial documents
2

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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