Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System

Boehringer Ingelheim

Status: Begins enrollment this month

Conditions: Gastric Surgery

Treatments: Device: Large Diameter ViSiGi LUX ™

Study type: Interventional

Funder types: Industry

Identifiers

NCT07572058

LDL-1

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Large Diameter ViSiGi LUX ™

Experimental group

Treatment:

Device: Large Diameter ViSiGi LUX ™