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NCT Number: NCT07385690

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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location contact

Lawrence Tabone, MD

CONTACT

[email protected]

304-293-3223

Lawrence Tabone, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Trocar slippage and Displacement

    Time frame: Day 1- At time of procedure

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

Secondary outcomes

  1. Percentage of Cases Without Fascial Closure at 12 mm Sites

    Time frame: Day 1- At time of procedure

    The proportion of surgical cases where fascial closure was not required at 12 mm trocar sites.

  2. Incidence of Trocar-Related Complications

    Time frame: Day 1- At time of procedure

    The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery.

  3. Ease of Use of Expansion Technique

    Time frame: Day 1- At time of procedure

    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.

  4. Frequency of Trocar Upsizing

    Time frame: Day 1- during procedure

    The percentage of trocar insertions requiring upsizing.

  5. Surgeon reported Ease of Trocar Upsizing

    Time frame: Day 1- during procedure

    The surgeon-reported ease of upsizing, rated on a 1-5 Likert scale (1 = difficult, 5 = easy) with 5 being the best outcome.

  6. Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing

    Time frame: Day 1- At time of procedure

    Percentage of successful maintenance of abdominal pathway and pneumoperitoneum during trocar upsizing.

  7. Total Procedure Time

    Time frame: Day 1- At time of procedure

    Total time (in minutes) from insufflation and trocar insertion to completion of the surgical procedure.

  8. Postoperative Analgesic Use

    Time frame: Up to 72 hours post procedure

    Percentage of participants reporting postoperative analgesic consumption.

  9. Time to Return to Normal Activity

    Time frame: 6 weeks post procedure

    Number of days until return to work or normal activity.

  10. Postoperative Pain Scores

    Time frame: 4 hours post procedure

    Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.

  11. Postoperative Pain Scores

    Time frame: 8 hours post procedure

    Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.

  12. Postoperative Pain Scores

    Time frame: 12 hours post procedure

    Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.

  13. Postoperative Pain Scores

    Time frame: 24 hours post procedure

    Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.

  14. Postoperative Pain Scores

    Time frame: 72 hours post procedure

    Pain scores measured postoperatively using a standardized pain scale (e.g., 0-10 Numeric Rating Scale) with 10 being the worst pain/outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Lawrence Tabone, MD

CONTACT

[email protected]

304-293-1728

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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