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NCT06282094 Clinical Trial

ViSiGi LUX Bariatric Sizing and Calibration System

Bariatric Surgery Candidate Clinical Trial

Official title:
ViSiGi LUX Bariatric Sizing and Calibration System Usability Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06282094
Other study ID # LUX
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2024
Est. completion date March 2024

Study information
Verified date March 2024
Source Boehringer Labs LLC
Contact Elena Lagunilla
Phone 4849312338
Email elagunilla@boehringerlabs.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the new ViSiGi LUX.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States WellSpan York Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Labs LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physician Feedback 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 6 months
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