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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02240550
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo routine inguinal hernia repair
* Male and Female patients between 18 and 65 years old
* Competent to give consent
* Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
* Defect size at operation is between 5mm and 35mm
* Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
* Primary hernia at the operative site
Exclusion Criteria:
* Signs of obvious local or systemic infection
* Any previous surgery on the hernia operative site
* Hernia is not in the inguinal area
* Hernia is not identified as indirect or direct
* Femoral hernias
* Known collagen disorder
* Presenting with unstable angina or NYHA class of IV
* Known Pregnancy or Nursing women
* Active drug user
* Recurrence of a repair by any method
* Patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
* Immunosuppression, prednisone\>15 mg/day, active chemotherapy
* End stage renal disease
* Abdominal ascites
* Skin infection in area of surgical field
* BMI \>35
* Peritoneum cannot be closed
* Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type)
* Neutropenia with absolute neutrophil count (ANC)\<500 cells/mm3
* Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure
* Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
* Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device
* Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
* Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
* Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02240550
Study Brief:
Protocol Section:
NCT02240550