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

Study Description

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Brief Summary:

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Condition or disease	Intervention/treatment	Phase
Ventral Hernia; Incisional Hernia	Device: Resorbable Mesh	Not Applicable

Detailed Description:

Pilot Study of patients across all wound classes for recurrence

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
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
Study Start Date :	February 2014
Actual Primary Completion Date :	February 23, 2017
Actual Study Completion Date :	February 23, 2017

Arms and Interventions

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Arm	Intervention/treatment
Resorbable Mesh; Phasix Mesh	Device: Resorbable Mesh; Phasix Mesh

Outcome Measures

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Primary Outcome Measures :

1. Hernia Recurrence Rate [ Time Frame: 12 Months ]

Secondary Outcome Measures :

1. Device related adverse events [ Time Frame: 24 Months ]
2. QOL assessments [ Time Frame: 24 Months ]
3. Surgical procedure time [ Time Frame: 10 Months ]
4. Length of hospital post Index Procedure [ Time Frame: 10 Months ]
5. Length of hospital stay [ Time Frame: 10 Months ]
6. Number of study related post operative surgical procedures and admissions. [ Time Frame: 24 Months ]
7. Number of study related post operative surgical procedure and admissions [ Time Frame: 24 Months ]
8. Number of related post-operative visits unrelated to standard of care [ Time Frame: 24 Months ]
9. Incidence of seroma [ Time Frame: 24 Months ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT02053168 History of Changes
Other Study ID Numbers:	DVL-HE-015
First Posted:	February 3, 2014
Last Update Posted:	April 13, 2017
Last Verified:	April 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