Xpan Non-Inferiority Study
West Virginia University
Summary
A trocar is a surgical instrument with a sharp point and tube and is used to create endoscopic access in the abdomen or chest where endoscopic instruments can be entered \& used in minimally invasive surgical procedures. Xpan has created an FDA Cleared radially dilating trocar (RDT) that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery. The purpose of this research protocol is to demonstrate that a new FDA Cleared Xpan® radially dilating trocar (RDT) system is at least, just as effective as the existing RDT trocar systems. The procedure will be performed using a radially dilating trocar that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery.
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals scheduled for the following procedures: * Sleeve Gastrectomy * Bypass * Revision \& other bariatric procedures * Robotic procedures * Bariatric patients Exclusion Criteria: * Any individual not scheduled for the above procedure and/or does not meet the age requirments.
Interventions
- DeviceXpan Trocar System
A radially dilating trocar system intended to reduce incision trauma by gradually dilating tissue rather than cutting. Allows initial placement at 3 mm and expansion up to 12 mm as needed for surgical access.
- DeviceStandard of Care (Non-expanding Trocar)
A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.
Location
- West Virginia UniversityMorgantown, West Virginia