Xpan Non-Inferiority Study

NCT07385690 | Not Yet Recruiting FDA Device

• 1 other identifier: 2506178705
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Trocar slippage and Displacement

  Percentage of trocars inserted for use during surgery that need to be adjusted or reinserted during surgical procedure due to slippage and/or displacement.

  Day 1- At time of procedure

Secondary Outcomes (14)

• Percentage of Cases Without Fascial Closure at 12 mm Sites

  Day 1- At time of procedure

• Incidence of Trocar-Related Complications

  Day 1- At time of procedure

• Ease of Use of Expansion Technique

  Day 1- At time of procedure

• Frequency of Trocar Upsizing

  Day 1- during procedure

• Surgeon reported Ease of Trocar Upsizing

  Day 1- during procedure

Study Arms (2)

Xpan Trocar System

ACTIVE COMPARATOR

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.

Device: Xpan Trocar System

Standard of Care (Non-expanding Trocar)

PLACEBO COMPARATOR

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.

Device: Standard of Care (Non-expanding Trocar)

Interventions

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.

Standard of Care (Non-expanding Trocar)

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.

Xpan Trocar System

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Study Officials

• Lawrence Tabone, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence Tabone, MD

CONTACT

304-293-1728; letabone@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chief of Division of General Surgery

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)