Trial record 8 of 178 for:    Open Studies | Hernia NOT disc

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by C. R. Bard
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT02053168
First received: January 31, 2014
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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: Allocation: Non-Randomized
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: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phasix Mesh Device: Phasix Mesh

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 more than once.
  • 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

Contacts
Contact: Rushil Sankpal 908-277-8082 rushil.sankpal@crbard.com

Locations
United States, California
Beverly Hills Hernia Center Recruiting
Beverly Hills, California, United States, 90210
Contact: Laura Sarmiento    310-423-4295    Laura.sarmiento@cshs.org   
Principal Investigator: Shirin Towfigh, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Laura Sarmiento    310-423-4295    Laura.sarmiento@cshs.org   
Principal Investigator: Shirin Towfigh, MD         
United States, Florida
Florida Hospital Celebration Health Recruiting
Celebration, Florida, United States, 34747
Contact: Kim Cartwritght, RN    407-303-4235    Kim.cartwright@flhosp.org   
Principal Investigator: Eduardo Parra Davila, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Christina Seafler, RN    216-844-4706    Christina.seafler@uhhospitals.org   
Principal Investigator: Yuri Novitsky, MD         
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Yuri Novitsky, MD University Hospital Case Medical Center
  More Information

No publications provided

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: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 26, 2014