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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04392635
Eligibility Criteria:
Inclusion Criteria:
* Age \>/= 18
* Scheduled for laparoscopic surgery
* Able to understand and willing to sign a written informed consent form
Exclusion Criteria:
* Age \< 18
* Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
* Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
* Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
* Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04392635
Study Brief:
Protocol Section:
NCT04392635