Xpan Non-Inferiority Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Device: Xpan Trocar System; Device: Standard of Care (Non-expanding Trocar)

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lawrence Tabone, MD; Phone Number: 304-293-1728; Email: letabone@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University
      • Contact: Lawrence Tabone, MD; Phone Number: 304-293-3223; Email: letabone@hsc.wvu.edu
      • Principal Investigator: Lawrence Tabone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals scheduled for the following procedures:

  • Sleeve Gastrectomy
  • Bypass
  • Revision & other bariatric procedures
  • Robotic procedures
  • Bariatric patients

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Cases Without Fascial Closure at 12 mm Sites	The proportion of surgical cases where fascial closure was not required at 12 mm trocar sites.	Day 1- At time of procedure
Incidence of Trocar-Related Complications	The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery.	Day 1- At time of procedure
Ease of Use of Expansion Technique	Surgeon-reported ease of use of the trocar expansion technique, rated on a 1-5 Likert scale (1 = difficult to use, 5 = easy to use) with 5 being the best outcome.	Day 1- At time of procedure
Frequency of Trocar Upsizing	The percentage of trocar insertions requiring upsizing.	Day 1- during procedure
Surgeon reported Ease of Trocar Upsizing	The surgeon-reported ease of upsizing, rated on a 1-5 Likert scale (1 = difficult, 5 = easy) with 5 being the best outcome.	Day 1- during procedure
Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing	Percentage of successful maintenance of abdominal pathway and pneumoperitoneum during trocar upsizing.	Day 1- At time of procedure
Total Procedure Time	Total time (in minutes) from insufflation and trocar insertion to completion of the surgical procedure.	Day 1- At time of procedure
Postoperative Analgesic Use	Percentage of participants reporting postoperative analgesic consumption.	Up to 72 hours post procedure
Time to Return to Normal Activity	Number of days until return to work or normal activity.	6 weeks post procedure
Postoperative Pain Scores	Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.	4 hours post procedure
Postoperative Pain Scores	Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.	8 hours post procedure
Postoperative Pain Scores	Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.	12 hours post procedure
Postoperative Pain Scores	Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.	24 hours post procedure
Postoperative Pain Scores	Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.	72 hours post procedure

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Lawrence Tabone, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2506178705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes