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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT02053168
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02053168
Study Brief:
Protocol Section:
NCT02053168