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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00646334
Eligibility Criteria:
Inclusion Criteria:
* Female or male patients \>=18 years
* Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation
* Patients wiht vertical aponeurotic incisions only
* Incisional hernia with hernia size \>= 3 cm
* Patient is capable to understand and to follow the instructions
* written informed consent
* no mesh implantation at the same site during a previous operation
* immune competence of patient
Exclusion Criteria:
* Simultanous participation in an investigational drug or medical device study
* Patients \< 18 years old
* Incisional Hernia withe a hernia size \< 3 cm
* Repair of an acute incarcerated hernia
* Previous mesh repair at the same site
* Patient with other than vertical aponeurotic incisions
* Enterotomy to be performed during hernia repair at Surgery
* Patient is on anti-coagulations-therapy
* Patient is known or assessed to be non-compliant
* Additional surgical treatment at the same time (e.g. cholecystectomy)
* Immune incompetence of patient (e.g. chemotherapy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00646334
Study Brief:
Protocol Section:
NCT00646334