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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT02053168
First received: January 31, 2014
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Condition Intervention
Ventral Hernia Incisional Hernia Device: Resorbable Mesh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Device related adverse events [ Time Frame: 24 Months ]
  • QOL assessments [ Time Frame: 24 Months ]
  • Surgical procedure time [ Time Frame: 10 Months ]
  • Length of hospital post Index Procedure [ Time Frame: 10 Months ]
  • Length of hospital stay [ Time Frame: 10 Months ]
  • Number of study related post operative surgical procedures and admissions. [ Time Frame: 24 Months ]
  • Number of study related post operative surgical procedure and admissions [ Time Frame: 24 Months ]
  • Number of related post-operative visits unrelated to standard of care [ Time Frame: 24 Months ]
  • Incidence of seroma [ Time Frame: 24 Months ]

Enrollment: 33
Study Start Date: February 2014
Study Completion Date: February 23, 2017
Primary Completion Date: February 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Resorbable Mesh
Phasix Mesh
Device: Resorbable Mesh
Phasix Mesh

Detailed Description:
Pilot Study of patients across all wound classes for recurrence
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Locations
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
Investigators
Principal Investigator: Yuri Novitsky, MD University Hospitals Cleveland 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: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on August 22, 2017