Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07572058

Enrollment

Registered

2026-05-07

Start date

2026-06-19

Completion date

2026-12-01

Last updated

2026-05-14

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

Conditions

Gastric Surgery

Brief summary

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

Interventions

DEVICELarge Diameter ViSiGi LUX ™

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Technical success rate	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.

Countries

United States

Contacts

CONTACTBarrett Genovese

bgenovese@boehringerlabs.com4849312294

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026