ViSiGi LUX Bariatric Sizing and Calibration System

March 11, 2024 updated by: Boehringer Labs LLC

ViSiGi LUX Bariatric Sizing and Calibration System Usability Study

This study investigates the new ViSiGi LUX.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • York, Pennsylvania, United States, 17405
        • Recruiting
        • Wellspan
        • Contact:
          • Faiz Shariff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing gastric or bariatric procedures.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Feedback
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Labs LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LUX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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