Xpan Non-Inferiority Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xpan Trocar System, Standard of Care (Non-expanding Trocar).
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Percentage of Trocar slippage and Displacement [Time frame: Day 1- At time of procedure]
Secondary outcome measures (12)
- Percentage of Cases Without Fascial Closure at 12 mm Sites [Time frame: Day 1- At time of procedure]
- Incidence of Trocar-Related Complications [Time frame: Day 1- At time of procedure]
- Ease of Use of Expansion Technique [Time frame: Day 1- At time of procedure]
- Frequency of Trocar Upsizing [Time frame: Day 1- during procedure]
- Surgeon reported Ease of Trocar Upsizing [Time frame: Day 1- during procedure]
- Percentage that Maintained Abdominal Pathway and Pneumoperitoneum During Upsizing [Time frame: Day 1- At time of procedure]
- Total Procedure Time [Time frame: Day 1- At time of procedure]
- Postoperative Analgesic Use [Time frame: Up to 72 hours post procedure]
- Time to Return to Normal Activity [Time frame: 6 weeks post procedure]
- Postoperative Pain Scores [Time frame: 4 hours post procedure]
- Postoperative Pain Scores [Time frame: 8 hours post procedure]
- Postoperative Pain Scores [Time frame: 12 hours post procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- West Virginia University — Morgantown
Identifiers
NCT: NCT07385690 · 2506178705