AzTrials
AzTrials

Bariatric Surgery CandidateNCT07385690

Xpan Non-Inferiority Study

A study testing Xpan Trocar System in people with Bariatric Surgery Candidate, run by West Virginia University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Bariatric Surgery Candidate
What is being tested?
Xpan Trocar System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteUnited States
Study dates
Feb 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals scheduled for the following procedures:
  • Sleeve Gastrectomy
  • Bypass
  • Revision \& other bariatric procedures
  • Robotic procedures
  • Bariatric patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lawrence Tabone, MD contact

304-293-1728

letabone@hsc.wvu.edu

United States1 site

  • West Virginia University

    Morgantown, West Virginia, 26505

    Lawrence Tabone, MD, 304-293-3223, letabone@hsc.wvu.edu

    Lawrence Tabone, MD

Other trials in United States

About this 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.

Being tested
Xpan Trocar System, Standard of Care (Non-expanding Trocar)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xpan Trocar SystemDevice

    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 groups in NCT07385690
Study groupRoleWhat they receive
Xpan Trocar SystemActive comparatorParticipants 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.
Receives: Device: Xpan Trocar System
Standard of Care (Non-expanding Trocar)Placebo comparatorParticipants 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.
Receives: Device: Standard of Care (Non-expanding Trocar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1- At time of procedure

Secondary outcomes (14)

  1. 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.

    Measured: Day 1- At time of procedure

  2. Incidence of Trocar-Related Complications

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

    Measured: Day 1- At time of procedure

  3. 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.

    Measured: Day 1- At time of procedure

  4. Frequency of Trocar Upsizing

    The percentage of trocar insertions requiring upsizing.

    Measured: Day 1- during procedure

  5. 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.

    Measured: Day 1- during procedure

  6. Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing

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

    Measured: Day 1- At time of procedure

  7. Total Procedure Time

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

    Measured: Day 1- At time of procedure

  8. Postoperative Analgesic Use

    Percentage of participants reporting postoperative analgesic consumption.

    Measured: Up to 72 hours post procedure

  9. Time to Return to Normal Activity

    Number of days until return to work or normal activity.

    Measured: 6 weeks post procedure

  10. 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.

    Measured: 4 hours post procedure

  11. 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.

    Measured: 8 hours post procedure

  12. 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.

    Measured: 12 hours post procedure

  13. 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.

    Measured: 24 hours post procedure

  14. 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.

    Measured: 72 hours post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385690
Sponsor's protocol ID
2506178705
Status last verified
Feb 2026
First submitted
26 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Xpan Trocar System in people with Bariatric Surgery Candidate, run by West Virginia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lawrence Tabone, MD (304-293-1728, letabone@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Trocar slippage and Displacement (time frame: Day 1- At time of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in