Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04855227
Eligibility Criteria:
Inclusion Criteria:
1. Subject is between 18 and 80 years of age.
2. Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
3. Ventral hernia repair that will require mesh placement
Exclusion Criteria:
1. Subject is contraindicated for general anesthesia or surgery.
2. Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
3. Subject has a recurrent hernia.
4. Subject who will have an emergent hernia repair.
5. Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
6. Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
7. Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
8. Subject with a history of MRSA infection.
9. Subject with HbA1c level \> 8.5%.
10. Use of Exparel during the surgical procedure.
11. Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
12. Current nicotine use (including vaping) within the past 30 days.
13. Subject has a known bleeding or clotting disorder.
14. Pregnant or suspected pregnancy.
15. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
16. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
17. Subject is currently participating in another interventional or investigational research study.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04855227
Study Brief:
Protocol Section:
NCT04855227