A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-11-30

Brief Summary

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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:

1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
2. Perioperative, short-term and long-term procedural and/or device related complications.
3. Abdominal Wall Function and mobility.

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Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Phasix mesh

Mesh being used for approved use. Mesh for ventral and incisional hernias.

Phasix mesh implant

Intervention Type DEVICE

Interventions

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Phasix mesh implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

The subject must meet all of the relevant criteria listed below to be enrolled in the study:

1. Subject must be ≥18 years of age.
2. Subject or subject's legally authorized representative must be willing give written informed consent.
3. Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
4. Hernia size greater than 10cm2 and less than 250cm2
5. 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:

1. Subject's hernia is multiply recurrent.
2. CDC wound classification other than clean or clean-contaminated
3. The use of surgical repair as a bridge.
4. Patient has a contraindication to placement of mesh.
5. Concomitant procedures with wound classification other than clean
6. Subject has peritonitis.
7. Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
8. Subject's body mass index (BMI) \>55 kg/m2.
9. Subject has cirrhosis, and/or ascites.
10. Subject is American Society of Anesthesiology Class 4 or 5.
11. Subject is known to be infected with human immunodeficiency virus (HIV).
12. Subject has known allergies to tetracycline or kanamycin.
13. Subject has a life expectancy of less than 2 years at the time of enrollment.
14. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No