Xpan Non-Inferiority Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorWest Virginia University

About this trial

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 criteria

Qualifiers

Sleeve Gastrectomy

Bypass

Revision & other bariatric procedures

Robotic procedures

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Xpan Trocar System
  • Standard of Care (Non-expanding Trocar)

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators