Investigation of the ViSiGi LUX device for bariatric surgery
ViSiGi LUX Bariatric Sizing and Calibration System Usability Study
This study is testing a new device that uses special lights to help surgeons see better during weight loss surgery to see if it improves results for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Boehringer Labs LLC Industry-sponsored |
| Locations | 1 site (York, Pennsylvania) |
| Trial ID | NCT06282094 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the ViSiGi LUX, a new device designed for use in gastric and bariatric procedures. The ViSiGi LUX enhances visualization during surgery with the addition of near-infrared (NIR) lights, potentially improving surgical outcomes. Participants will be individuals who are candidates for robotic bariatric surgery and meet specific eligibility criteria. The study aims to gather data on the effectiveness and utility of this innovative device in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are eligible for robotic bariatric surgery.
Not a fit: Patients with esophageal strictures or conditions that prevent them from undergoing gastric or bariatric surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could improve the safety and effectiveness of bariatric surgeries for patients.
How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success with devices incorporating NIR visualization in bariatric surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * able to consent * candidate for robotic bariatric surgery Exclusion Criteria: * esophageal stricture that does not allow passage of the device * conditions that would preclude gastric or bariatric surgical procedures * pregnant patients
Where this trial is running
York, Pennsylvania
- WellSpan — York, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Elena Lagunilla
- Email: elagunilla@boehringerlabs.com
- Phone: 4849312338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.