ViSiGi LUX Bariatric Sizing and Calibration System

ViSiGi LUX Bariatric Sizing and Calibration System Usability Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06282094

Enrollment

Registered

2024-02-28

Start date

2024-01-26

Completion date

2024-03-31

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactElena Lagunilla

elagunilla@boehringerlabs.com4849312338

Outcome results