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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT06445504
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects (age ≥ 22 years) as required by local law
* Subject has been indicated for one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). Multiple small hernia defects are allowed with total distance of combined defects being \< 10cm (b.) inguinal (unilateral or bilateral) hernia(s).
* Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
* The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form
Exclusion Criteria:
* Patients for which minimally invasive surgery is contraindicated as determined by the Investigator
* Patients with a recurrent hernia
* Subjects with femoral hernia defects
* Subjects with ventral hernia defect(s) located in M1, M5, or L4
* Patients with emergent hernia repair
* Ventral hernia is CDC (Center for Disease Control) grade 2 or higher
* Use of component separation techniques to close the hernia defect
* Inability to close the hernia defect
* Hernia defect is ≥ 10 cm
* Patient has BMI \> 40
* Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
* Patients diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
* Female patients pregnant at the time of the surgical procedure.
* Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
* Patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
* Patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06445504
Study Brief:
Protocol Section:
NCT06445504