NCT01863030CompletedNot Applicable
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
John Roth1 site in 1 country31 target enrollmentStarted: May 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Study Overview
Brief Summary
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:
- Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
- Perioperative, short-term and long-term procedural and/or device related complications.
- Abdominal Wall Function and mobility.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subject must meet all of the relevant criteria listed below to be enrolled in the study:
- •Subject must be ≥18 years of age.
- •Subject or subject's legally authorized representative must be willing give written informed consent.
- •Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
- •Hernia size greater than 10cm2 and less than 250cm2
- •Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion Criteria
- •The subject must be excluded from study enrollment if any of the following criteria are met:
- •Subject's hernia is multiply recurrent.
- •CDC wound classification other than clean or clean-contaminated
- •The use of surgical repair as a bridge.
- •Patient has a contraindication to placement of mesh.
- •Concomitant procedures with wound classification other than clean
- •Subject has peritonitis.
- •Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
- •Subject's body mass index (BMI) >55 kg/m
- •Subject has cirrhosis, and/or ascites.
- •Subject is American Society of Anesthesiology Class 4 or
- •Subject is known to be infected with human immunodeficiency virus (HIV).
- •Subject has known allergies to tetracycline or kanamycin.
- •Subject has a life expectancy of less than 2 years at the time of enrollment.
- •Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
Outcomes
Primary Outcomes
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Time Frame: up to 24 months post surgery
Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
Secondary Outcomes
No secondary outcomes reported
Investigators
John Roth
PI
University of Kentucky
Study Sites (1)
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