NCT07572058

Brief Summary

This study investigates the use of the large diameter Visigi LUX

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

April 22, 2026

Last Update Submit

May 4, 2026

Conditions

Gastric Surgery

Outcome Measures

Primary Outcomes (1)

  • Technical success rate

    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.

    6 months

Study Arms (1)

Large Diameter Visigi LUX

EXPERIMENTAL
Device: Large Diameter Visigi LUX

Interventions

Large Diameter Visigi LUXDEVICE

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.

Large Diameter Visigi LUX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Barrett Genovese

CONTACT

4849312294bgenovese@boehringerlabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05