A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
First received: January 31, 2014
Last updated: March 14, 2016
Last verified: March 2016
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Condition Intervention Phase
Ventral Hernia
Incisional Hernia
Device: Phasix Mesh
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair

Resource links provided by NLM:

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Hernia Recurrence Rate [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device related adverse events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • QOL assessments [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Surgical procedure time [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
  • Length of hospital post Index Procedure [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 10 Months ] [ Designated as safety issue: No ]
  • Number of study related post operative surgical procedures and admissions. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Number of study related post operative surgical procedure and admissions [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Number of related post-operative visits unrelated to standard of care [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Incidence of seroma [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phasix Mesh Device: Phasix Mesh


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject or subject's legally authorized representative must be willing to give written informed consent
  • Subject must be diagnosed with ventral or incisional hernia
  • Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria:

  • Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
  • Subject's hernia has recurred four or more times.
  • Subject's body mass index (BMI) >40 kg/m2.
  • Subject has peritonitis.
  • Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
  • Chronic steroid use or immunosuppression drugs (> 6 months).
  • Subject has cirrhosis, and/or ascites.
  • Subject is American Society of Anesthesiology Class 4 or 5.
  • Subject is pregnant or planning to become pregnant during the course of the study.
  • Subject is known to be infected with human immunodeficiency virus (HIV).
  • Subject has a life expectancy of less than 2 years at the time of enrollment.
  • Subject has been treated with an investigational product in the past 30 days.
  • Subject is part of the site personnel directly involved with this study
  • Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
  • Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053168

United States, California
Beverly Hills Hernia Center
Beverly Hills, California, United States, 90210
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
United States, Nebraska
Methodist Physicians Clinic
Omaha, Nebraska, United States, 68114
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Yuri Novitsky, MD University Hospital Case Medical Center
  More Information

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02053168     History of Changes
Other Study ID Numbers: DVL-HE-015 
Study First Received: January 31, 2014
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia, Ventral
Incisional Hernia
Hernia, Abdominal
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications

ClinicalTrials.gov processed this record on May 24, 2016