Xpan Non-Inferiority Study
ConditionBariatric Surgery Candidate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sleeve Gastrectomy
Bypass
Revision & other bariatric procedures
Robotic procedures
Disqualifiers
Any individual not scheduled for the above procedure and/or does not meet the age requirments.
Trial design
Design model
Parallel
Treatments tested in this trial
Xpan Trocar System
DeviceA 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)
DeviceA surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Xpan Trocar SystemActive comparator 1 intervention
Group B: Standard of Care (Non-expanding Trocar)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Day 1- At time of procedureSecondary outcomes
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.
Time frame
Day 1- At time of procedure2
Incidence of Trocar-Related Complications
The number of trocar-related complications (e.g., bleeding, infection, loss of pneumoperitoneum) observed during surgery.
Time frame
Day 1- At time of procedure3
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.
Time frame
Day 1- At time of procedure4
Frequency of Trocar Upsizing
The percentage of trocar insertions requiring upsizing.
Time frame
Day 1- during procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: