Xpan Non-Inferiority Study

February 2, 2026 updated by: Lawrence Tabone, West Virginia University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Lawrence Tabone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1- At time of procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1- At time of procedure
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.
Day 1- At time of procedure
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.
Day 1- At time of procedure
Frequency of Trocar Upsizing
Time Frame: Day 1- during procedure
The percentage of trocar insertions requiring upsizing.
Day 1- during procedure
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.
Day 1- during procedure
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.
Day 1- At time of procedure
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.
Day 1- At time of procedure
Postoperative Analgesic Use
Time Frame: Up to 72 hours post procedure
Percentage of participants reporting postoperative analgesic consumption.
Up to 72 hours post procedure
Time to Return to Normal Activity
Time Frame: 6 weeks post procedure
Number of days until return to work or normal activity.
6 weeks post procedure
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.
4 hours post procedure
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.
8 hours post procedure
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.
12 hours post procedure
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.
24 hours post procedure
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.
72 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lawrence Tabone, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bariatric Surgery Candidate

Clinical Trials on Xpan Trocar System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings