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:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02587403
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or greater
* Have a BMI \< or equal to 40
* Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects whose combined area is ≥ an estimated 200 cm2. Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure
* Have no contraindications to the test material (s)
* Have a life expectancy greater than 1 year in the opinion of the Investigator
* Able to provide informed consent
* Able and willing to return for scheduled study visits over 2 years post-operatively (following research related surgery)
Exclusion Criteria:
* \< 18 years of age
* Subject is determined to have an American Society of Anesthesiologists'(ASA) physical class of 4, 5, or 6
* Have a BMI \>40
* Have a hernia estimated to be \<200 cm2
* Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the investigator
* Inability to close the fascia primarily without abdominal wall mobilization or component separation
* Participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial
* Have active necrotizing fasciitis or any other known active local or systemic infection
* Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
* Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC or SCC
* Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial
* Have a life expectancy less than 1 year
* Be unable to participate in the informed consent process
* Be unable or unwilling to return for scheduled study visits over the 2 year post-operative assessment period
* Received high dose steroids (\>/=100mg of prednisone) within the past 6 weeks
* Known tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
* Uncontrolled diabetes (i.e. known HbA1C value \> 7% within the last 6 weeks)
* History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
* Pregnancy and/or breastfeeding
* Enterocutaneous fistula
* Ventral hernia repairs involving active infection
* Inability to obtain primary fascial closure (Intra-operatively)
* Planned use of external VAC dressing intra-operatively
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02587403
Study Brief:
Protocol Section:
NCT02587403