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NCT Number: NCT07572058

Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System

This study investigates the use of the large diameter ViSiGi LUX ™

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Key information

Conditions

Gastric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Able to consent
  • Candidate for laparoscopic gastric surgery

Exclusion criteria

  • Esophageal stricture that does not allow passage of the device
  • Conditions that would preclude gastric surgical procedures
  • Pregnant patients
  • Non-English-speaking patients

Treatment and study plan

Large Diameter ViSiGi LUX ™

Device

ViSiGi LUX ™ is used during numerous gastric procedures. This new device functions the same as ViSiGi LUX ™ but has an increased diameter representative of existing devices used more frequently in upper gastric procedures.

Primary outcomes

  1. Technical success rate

    Time frame: 6 months

    Successful introduction of the sizing and calibration system, correct positioning and function intraoperatively will be logged following each use of the device. This will be assessed by the operating physician.

Study contacts

Contact information is provided by the study sponsor or research team.

Barrett Genovese

CONTACT

[email protected]

4849312294

Sponsors and collaborators

Lead sponsor

Boehringer Labs LLC

Industry

Registry information

Official study title

Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System Usability Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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