A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix Mesh for VHWG Grade 3 Midline Hernia Repair
- Conditions
- hernia cicatricalisIncisional herniaventral hernia10041297
- Registration Number
- NL-OMON46922
- Lead Sponsor
- Davol Inc.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
The subject must meet all of the criteria listed below to be enrolled in the study:
1. Subject must be 18 years of age or older.
2. Subject must be diagnosed with incisional midline hernia.
3. Subject has a VHWG Grade 3 hernia (as defined in 5.2.3).
4. Size of hernia * 10 cm2.
5. Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique (CST).
6. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study*s provisions, and has duly signed the informed consent form (ICF). Subject agrees to comply with the protocol-mandated procedures and visits.
The subject must be excluded from study enrollment if any of the following criteria are met:
1. Subject with > 4 previous repairs of the hernia under observation.
2. Body Mass Index (BMI) > 35 kg/m2.
3. The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
4. The subject has peritonitis.
5. Known human immunodeficiency virus (HIV) infection (if documented in the subject*s record).
6. The subject has cirrhosis of the liver and/or ascites.
7. Subject is American Society of Anesthesiology Class 4 or 5.
8. Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
9. The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
10. Subject has intact permanent mesh adjacent to the current hernia to be repaired.
11. Subject*s hernia repair requires intraabdominal mesh placement.
12. Surgical technique requires surgical bridge repair as the sole repair.
13. 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.
14. Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
15. Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
16. Subject was involved in another interventional clinical study in the last 30 days prior to ICF signature.
17. Subject is part of the site personnel directly involved with this study.
18. Subject has a life expectancy of less than 2 years at the time of enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Surgical Site Occurrence (SSO) rate up to and including, the 3-month (± 14<br /><br>days) follow-up assessment.<br /><br><br /><br>Occurrences at the surgical site will be assessed by physical examination at<br /><br>each study visit through 3 months (± 14 days). Surgical site occurrence will be<br /><br>defined as hematoma, seroma, surgical site infection, wound dehiscence, skin<br /><br>necrosis and fistula requiring intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Surgical Site Occurrence (SSO) rate > 3-month follow-up assessment<br /><br>2. Hernia Recurrence Rate (via physical exam, if uncertain via ultrasonography,<br /><br>if uncertain, via CT/MRI)<br /><br>3. Surgical Site Infection rate (see 18.1)<br /><br>4. Pain - Visual Analog Scale (VAS)<br /><br>5. Device related adverse event incidence<br /><br>6. Rate of reoperation due to the index hernia repair<br /><br>7. Quality of life assessments (Carolinas Comfort Scale® and EQ-5D*)<br /><br>8. Surgical procedure time as measured from incision to closure (skin to skin)<br /><br>9. Return to work<br /><br>10. Length of hospital stay (day of index surgery until day of discharge, LOS)</p><br>