ViSiGi LUX Bariatric Sizing and Calibration System

NCT ID: NCT06282094

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-03-31

Brief Summary

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This study investigates the new ViSiGi LUX.

Detailed Description

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Labs LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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WellSpan

York, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elena Lagunilla

Role: CONTACT

4849312338

Facility Contacts

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Faiz Shariff

Role: primary

Other Identifiers

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LUX

Identifier Type: -

Identifier Source: org_study_id

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