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Clinical Trials/NCT06282094
NCT06282094RecruitingNot Applicable

ViSiGi LUX Bariatric Sizing and Calibration System Usability Study

Boehringer Labs LLC1 site in 1 country30 target enrollmentStarted: January 26, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Physician Feedback
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Boehringer Labs LLC
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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