Xpan Non-Inferiority Study

Starting soon · Not applicable

Conditions studied: Bariatric Surgery Candidate

In brief

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.

Key facts

Study ID

NCT07385690

Run by

West Virginia University

People needed

35

Starts

2026-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals scheduled for the following procedures:
• Sleeve Gastrectomy
• Bypass
• Revision \& other bariatric procedures
• Robotic procedures
• Bariatric patients

You may not qualify if…

• Any individual not scheduled for the above procedure and/or does not meet the age requirments.

Where it is running

• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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