Unknown PHASE1 INTERVENTIONAL 2-arm NCT02008825

Evaluation of the ViSiGiTM Calibration System (ViSiGi)

Evaluation of the ViSiGiTM Calibration System for Effectiveness With Sleeve Visual Delineation at Various Suction Levels.

Sponsor: Boehringer Ingelheim

Conditions Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed; Ensure Consistent and Reproducible Staple Lines. Increase the Safety Profile of the Patient (i.e., Reduce the Likelihood of Accidental Stapling of the Orogastric Tube or Bougie); Reduce the Incidence of OR Contamination/Infection Transmission; Streamline OR Workflow, Resulting in Reduced OR Time

Interventions Usual non suction Bougie Utilization of ViSiGi calibration tube

Updated 5 times since 2017 Last updated: Dec 10, 2013 Started: Jan 31, 2014 Primary completion: Apr 30, 2014 Completion: May 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed; and Ensure Consistent and Reproducible Staple Lines., this trial is ongoing. The trial is conducted by Boehringer Ingelheim and has accumulated 5 data snapshots since 2014. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Unknown PHASE1
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE1

Status: Unknown Status → Unknown
Jan 2021 — Jul 2024 [monthly]

Unknown Status PHASE1
Jun 2018 — Jan 2021 [monthly]

Unknown Status PHASE1
Jan 2017 — Jun 2018 [monthly]

Unknown Status PHASE1

First recorded

Jan 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boehringer Ingelheim
St. Luke's Hospital and Health Network, Pennsylvania

Data source: St. Luke's Hospital and Health Network, Pennsylvania

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Allentown, United States