NCT07385690

Xpan Non-Inferiority Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DEVICE	Xpan 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.
DEVICE	Standard 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study