Clinical trial NCT02053168: A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Official title: A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Incisional Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Number of Participants With Hernia Recurrence
timeFrame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
Secondary outcomes:
measure: Number of Participants With Device Related Adverse Events
timeFrame: 24 Months
measure: Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
timeFrame: Baseline and 24 months postoperative
measure: Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
timeFrame: Baseline and 24 months postoperative
measure: Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
timeFrame: Baseline and 24 months postoperative
measure: Surgical Procedure Time
timeFrame: Duration of index procedure (mean of 242.5 mins)
measure: Length of Hospital Stay
timeFrame: 10 Months
measure: Number of Study Related Post Operative Surgical Procedures
timeFrame: 24 Months
measure: Number of Study Related Post Operative New Hospital Admissions
timeFrame: 24 Months
measure: Number of Related Post-operative Visits Unrelated to Standard of Care
timeFrame: 24 Months
measure: Incidence of Seroma
timeFrame: 24 Months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Hernia Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Omaha
country: United States
facility: Methodist Physicians Clinic
state: Nebraska
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Yuri Novitsky, MD
role: PRINCIPAL_INVESTIGATOR
References: