Not yet recruiting NCT07572058
Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Large Diameter ViSiGi LUX ™.
- Who it may be relevant to
- Registry conditions: Gastric Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System Usability Study
Overview
This study investigates the use of the large diameter ViSiGi LUX ™
Interventions
- Device Large 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.
Primary outcome measures
- Technical success rate [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Eisenhower Medical Center — Rancho Mirage
Identifiers
NCT: NCT07572058 · LDL-1