Device to Assist With Abdominal Access During Laparoscopic Surgery
Trial ID or NCT#
NCT04392635
Status
RECRUITING
Purpose
The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.
Official Title
Pilot Study to Establish Safety and Ease of Use of a Trocar Placement Access Device (TPAD) for Laparoscopic Surgery
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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.
Contact us to find out if this trial is right for you.
Contact
Study Team
650-736-2776
View on ClinicalTrials.gov
