Xpan Non-Inferiority Study

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT07385690
Status
Not Yet Recruiting

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Conditions

  • Bariatric Surgery Candidate

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Xpan Trocar System — DEVICE
    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.
  • Standard of Care (Non-expanding Trocar) — DEVICE
    A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.

Study Details

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 Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Xpan Trocar System
    Participants will undergo laparoscopic surgery using the Xpan Trocar System. Standard insertion technique will be used to create a 3 mm punch into an already gas-extended abdomen. A total of 3-5 trocars will be placed based on the type of surgery. Once placed, trocars will be radially dilated to the size necessary for the procedure, generally 2 trocars expanded to 5 mm and 2 trocars expanded to 12 mm. Final trocar size will range from 3 mm to 12 mm. Both placement and final dilated size will be documented.
  • Placebo Comparator: Standard of Care (Non-expanding Trocar)
    Participants will undergo laparoscopic surgery using a non-expanding trocar, which is considered the institutions standard of care for the procedure. Trocar size is selected based on surgical requirements and remain fixed throughout the procedure.

Primary Outcome Measure

Percentage of Trocar slippage and Displacement [ Time Frame: Day 1- At time of procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia UniversityMorgantownWest Virginia26505
Lawrence Tabone, MD
[email protected]
304-293-3223
Lawrence Tabone, MD (PRINCIPAL_INVESTIGATOR)

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West Virginia University· Morgantown, WV

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