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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT00749268
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
* Age \> 18 years
* Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use
Exclusion Criteria:
* Pregnancy
* Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
* Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
* History of alcohol or drug abuse within 6 months prior to screening
* History of chronic pain condition requiring more than 30 days of medical management
* Use of an additional nonresorbable means of fixation (inguinal)
* Patients considered not able to comply with the protocol and follow up schedule
* ASA grade of 4 or above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00749268
Study Brief:
Protocol Section:
NCT00749268