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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT02401334
Eligibility Criteria:
Inclusion Criteria:
* Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
Exclusion Criteria:
* Body Mass Index (BMI) \< 25.
* Body weight \< 45 kg
* Glycosylated Hemoglobin (Hgb A1c) \> 10%
* Albumin \< 2.5 g/dL or pre-albumin \< 5.0 mg/dL
* Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2
* Known allergies to study device components
* Other relevant exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02401334
Study Brief:
Protocol Section:
NCT02401334