ViSiGi LUX Bariatric Sizing and Calibration System

Recruiting

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT06282094
• Lead Sponsor: Boehringer Labs LLC

Brief Summary

This study investigates the new ViSiGi LUX.

Detailed Description

ViSiGi is used during numerous gastric and bariatric procedures. The new device, ViSiGi LUX functions as the FDA-cleared ViSiGi but has the added visualization of NIR lights.

Study Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Primary Completion: 2024-03
• Study Completion: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician Feedback	6 months	The physician provides feedback and comments on the usability of the device. The physician will rate the device on a Likert scale. 1-7 higher score is better

Trial Locations

Locations (1)

WellSpan; 🇺🇸 York, Pennsylvania, United States