Xpan Trocar System for Bariatric Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new surgical tool called the Xpan Trocar System, designed for minimally invasive surgeries like sleeve gastrectomy and bypass. The researchers aim to determine if this expandable tool performs as well as traditional tools. Participants will undergo surgery with either the new expanding tool or the standard fixed-size tool for comparison. The trial seeks individuals already scheduled for specific bariatric (weight-loss) procedures. As an unphased trial, it offers participants the chance to contribute to advancements in surgical technology.
What prior data suggests that the Xpan Trocar System is safe for bariatric surgery?
Research has shown that the Xpan Trocar System is generally safe for surgeries. The FDA has approved this system, confirming it meets specific safety standards for medical devices. The Xpan Trocar starts at 3mm and can expand to 12mm, which may reduce the risk of complications often seen with larger, fixed-size devices.
Safety tests ensured the Xpan Trocar System's safety before use in people. Although laparoscopic surgery, a type of minimally invasive surgery, carries risks, starting with a smaller size like Xpan's could potentially lower the chances of problems.
Evidence so far suggests that the Xpan Trocar System is well-tolerated, with safety measures in place to minimize adverse events. This provides confidence for those considering joining a trial using this system.12345Why are researchers excited about this trial?
Researchers are excited about the Xpan Trocar System for bariatric surgery because it offers a novel approach to surgical entry. Unlike standard non-expanding trocars, which remain a fixed size, the Xpan Trocar System allows for the dilation of trocars after insertion. This means that surgeons can use smaller initial incisions, potentially reducing patient trauma and improving recovery times. Additionally, the ability to expand trocars up to 12 mm provides flexibility to accommodate different surgical needs, which could enhance the overall efficiency and precision of the procedure.
What evidence suggests that the Xpan Trocar System is effective for bariatric surgery?
This trial will compare the Xpan Trocar System with the standard of care using non-expanding trocars. Research has shown that the Xpan Trocar System is designed to perform as well as current surgical tools. The system begins with a small 3mm opening and can expand to 5mm or 12mm, offering more flexibility during surgery. Its key feature is the ability to change sizes during the procedure, potentially causing less damage than fixed-size tools. Although direct evidence of its effectiveness in people is limited, the FDA has cleared it, indicating it meets certain safety and performance standards. Overall, the system aims to provide similar results to existing tools but with greater flexibility and adaptability.16789
Who Is on the Research Team?
Lawrence Tabone, MD
Principal Investigator
West Virginia University
Are You a Good Fit for This Trial?
This trial is for individuals who are candidates for bariatric surgery, a type of weight-loss procedure. Participants must meet certain health criteria to join the study but specific inclusion and exclusion details were not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic surgery using either the Xpan Trocar System or a non-expanding trocar
Immediate Postoperative Monitoring
Participants are monitored for trocar-related complications and postoperative analgesic use
Follow-up
Participants are monitored for safety and effectiveness, including time to return to normal activity and postoperative pain scores
What Are the Treatments Tested in This Trial?
Interventions
- Xpan Trocar System
Trial Overview
The Xpan Trocar System, which starts at 3mm and expands to 5mm or 12mm during surgery, is being tested against standard non-expanding trocars used in minimally invasive surgeries.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
West Virginia University
Lead Sponsor
Citations
Study Details | NCT07385690 | Xpan Non-Inferiority Study
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 ...
Comparative Effectiveness and Safety of Bariatric Procedures ...
At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points ...
Comparative effectiveness of 3 bariatric surgery procedures
Conclusion: For the short term, RYGB appears to achieve better weight reduction and management of obesity-associated co-morbid conditions compared with the SG ...
4.
researchgate.net
researchgate.net/publication/312526796_Comparative_effectiveness_of_primary_bariatric_operations_in_the_United_StatesComparative effectiveness of primary bariatric operations ...
25, 26 Cohort studies at 1 to 5 years' follow-up show rates of reoperation following bariatric surgery ranging from 5% to 22% and are higher after RYGB compared ...
Long-Term Outcomes of Roux-en-Y Bypass, Sleeve ...
A national study shows prostate cancer screening rates more than doubled after bariatric surgery, making these patients the most screened group.
Safety and Efficacy of Trocar Port-Site Closure Using a ... - PMC
Although generally safe, laparoscopic surgery is not without complications. The greater the trocar diameter, the higher the reported incidence ...
Safety and Efficacy of Trocar Port-Site Closure Using a ...
Conclusion: Closure of port-site trocar incisions using Cutanplast plug is fast, efficient, with potential to reduce operating times and ...
June 2, 2023 Xpan Inc. Michele Lucey Consultant Lakeshore ...
Performance Data: Nonclinical performance data has been conducted for the Xpan Universal Trocar System was conducted to evaluate safety and ...
(PDF) Safety and Efficacy of Trocar Port-Site Closure Using ...
PDF | Purpose Port-site trocar closure is a challenging procedure in laparoscopic surgeries, especially in morbidly obese patients, and complications.
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