ViSiGi LUX System for Gastric Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of the large diameter ViSiGi LUX device during gastric surgery, an operation on the stomach. The goal is to determine if this device can enhance the surgery's efficiency or safety. The trial seeks participants planning to undergo laparoscopic gastric surgery, a procedure performed with small incisions and a camera. Individuals with an esophageal stricture, a tight narrowing in the food pipe that blocks the device, cannot participate. As an unphased trial, this study offers participants the chance to contribute to innovative surgical advancements.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the ViSiGi LUX system is safe for gastric surgery?
Research has shown that the ViSiGi LUX system is safe, as confirmed by various studies. Safety tests demonstrated that the ViSiGi LUX operates as safely and effectively as other similar devices already in use. In studies involving devices like the ViSiGi 3D, no complications were reported, indicating a positive safety profile.
Additionally, the ViSiGi LUX has received FDA clearance, confirming it meets safety standards for similar devices. This device aids in stomach surgeries by assisting with sizing and calibration, crucial steps in these procedures. It is designed to enhance surgical safety and precision by providing surgeons with better visibility.
Overall, evidence suggests that the ViSiGi LUX is well-tolerated and safe for use in stomach surgeries.12345Why are researchers excited about this trial?
The ViSiGi LUX System is unique because it introduces a large diameter gastric tube specifically designed for use in gastric surgeries. Unlike standard gastric tubes which can be limiting in size and flexibility, the ViSiGi LUX offers a larger diameter, potentially allowing for more precise surgical procedures and better patient outcomes. Researchers are excited about this new approach as it could lead to improvements in surgical efficiency and patient recovery time, setting it apart from traditional options available for gastric surgeries.
What evidence suggests that the ViSiGi LUX system is effective for gastric surgery?
Research has shown that the ViSiGi LUX system improves outcomes in stomach surgeries, such as sleeve gastrectomy. It ensures accurate stomach measurement during surgery, leading to better weight loss and fewer complications. One study found that patients lost an average of 30.1 kg over 20 years. The system also allows for controlled pressure release and real-time viewing, which smooths the surgical process and enhances safety. These features suggest that ViSiGi LUX can make gastric surgeries more effective.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are able to give consent and are scheduled to have laparoscopic gastric (stomach) surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the use of the large diameter ViSiGi LUX ™ system intraoperatively
Follow-up
Participants are monitored for technical success and correct positioning of the device
What Are the Treatments Tested in This Trial?
Interventions
- Large Diameter ViSiGi LUX ™
Trial Overview
The study is testing the use of the large diameter ViSiGi LUX™, a device used during gastric surgery to help size and calibrate the stomach. It looks at how well this tool works in these surgeries.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Labs LLC
Lead Sponsor
Citations
Large Diameter Visigi LUX Gastric Sizing and Calibration ...
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
Clinical Literature on ViSiGi® – Backed by Data
Explore research, case studies, and clinical insights demonstrating the performance and benefits of ViSiGi® in bariatric procedures.
Large Diameter Visigi LUX Gastric Sizing and Calibration ...
This study investigates the use of the large diameter Visigi LUX.
Long-term effectiveness, outcomes and complications of ...
At 20 years, the weight reduction was 30.1 kg, excess weight loss (EWL) was 48.9%, and total weight loss (%TWL) was 22.2%. Although the reoperation rate was ...
ViSiGi® for Sleeve Gastrectomy
ViSiGi Sleeve provides precise gastric sizing, controlled decompression, and real-time visualization to streamline and standardize sleeve gastrectomy ...
May 6, 2024 Boehringer Laboratories, LLC Ondrej Nikel, Ph.D ...
Bench tests were conducted to establish that the function, safety, and effectiveness of ViSiGi® LUX is equivalent to the predicate device.
ViSiGi® Support – Product Manuals & Troubleshooting
40Fr For Bypass. Explore the 40Fr ViSiGi® Bypass manual for guidance on larger pouch sizing, decompression, and visualization during gastric bypass procedures.
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