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Evaluation of the ViSiGiTM Calibration System

NCT02008825 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-12-11

No results posted yet for this study

Summary

We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will:

1. enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent of gastric volume to be removed;
2. increase the safety profile of the patient (i.e., reduce the likelihood of accidental stapling of the orogastric tube or bougie);
3. reduce the incidence of OR contamination/infection transmission;
4. streamline OR workflow, resulting in reduced OR time; and
5. ensure consistent and reproducible staple lines.

Conditions

  • Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed;
  • 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
  • Ensure Consistent and Reproducible Staple Lines.

Interventions

DEVICE

Utilization of ViSiGi calibration tube

Utilization of ViSiGi calibration tube

DEVICE

Usual non suction Bougie

Usual non suction Bougie

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • St. Luke's Hospital and Health Network, Pennsylvania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008825 on ClinicalTrials.gov