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

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

Detailed Description
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Pilot Study of patients across all wound classes for recurrence

Official Title
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A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair

Conditions
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Ventral Hernia, Incisional Hernia

Intervention / Treatment
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* Device: Resorbable Mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Resorbable Mesh<br>Phasix Mesh | Device: Resorbable Mesh<br>* Phasix Mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hernia Recurrence | A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. | 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Device Related Adverse Events | In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. | 24 Months | 
| Carolinas Comfort Scale (CCS) Total Score - Change From Baseline | The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative | 
| Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative | 
| Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) | Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline. | Baseline and 24 months postoperative | 
| Surgical Procedure Time | Measured from incision to closure (skin to skin). | Duration of index procedure (mean of 242.5 mins) | 
| Length of Hospital Stay | Measured from end of index procedure to hospital discharge | 10 Months | 
| Number of Study Related Post Operative Surgical Procedures |  | 24 Months | 
| Number of Study Related Post Operative New Hospital Admissions |  | 24 Months | 
| Number of Related Post-operative Visits Unrelated to Standard of Care |  | 24 Months | 
| Incidence of Seroma |  | 24 Months |