Evaluation of the ViSiGiTM Calibration System (ViSiGi)

December 10, 2013 updated by: Leonardo Claros, St. Luke's Hospital and Health Network, Pennsylvania

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic Sleeve Gastrectomy (LSG), is now widely used as a stand-alone procedure for long-term weight loss. With fewer potential morbidities, comparable weight loss and greater ease of conversion to other procedures, many patients now opt for LSG as their bariatric procedure of choice. During surgery gastric decompression and calibration are compulsory for patient safety, gastric anatomic delineation, ease of surgery and optimal weight loss. The removed gastric volume at surgery seems to predict the procedure's success rates2. LSG performed without calibration (tube) could result in inconsistent staple lines, with retained high sleeve volume and consequent failure. Traditionally, although different tubes are used for gastric decompression and calibration, this protocol interrupts operation room (0R) workflow. Accidental stapling of orogastric tubes and bougies do occur in the OR but are seldom reported. The need for this multiple tube system can be obviated with the ViSiGi™ Calibration Tube System. A single, multipurpose tube that integrates all these various steps could prevent breaks in OR; improve workflow; reduce patient injuries, cross contamination and transmission of infections; and a consistent and reproducible staple line. A similar device has been in use in Europe, Australia and Asia, but the ViSiGi™ Calibration Tube System is the first of its kind to be approved by the FDA. Currently, there are no data on its clinical safety/efficacy in comparison to standard care of separate orogastric tube and bougie in the United States. Therefore, this exploratory study will investigate the gastric delineation ability, general safety and efficacy of the ViSiGi™ Calibration Tube System along with the regular bougie in LSG patients over a six- to twelve-month period. Descriptive outcomes will be reported, with no formal sample size calculation in light of the exploratory study design.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Saint Luke's University and Health Network
        • Contact:
        • Principal Investigator:
          • Leonardo Claros, MD
        • Sub-Investigator:
          • Maher ElChaar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ability to provide written informed consent for study participation.
  • age 18 years or older
  • candidate for laparosopic gastrectomy with no history of previous bariatric surgeries (i.e., gastric bypass, band, duodenal switch)attendance at an informational seminar and support group
  • clearance for surgery by a registered dietician and certified social worker
  • BMI > 35 with at least one co-morbid condition (e.g., hypertension, diabetes mellitus, sleep apnea, hypercholesterolemia) or BMI > 40 without any co-morbid conditions
  • negative pregnancy test
  • American Society of Anesthesiology score 1-3
  • ability to understand instructions and comply with all study requirements
  • pre-operative %excess weight loss (%EWL) of 3-10%
  • no contraindication for LSG based on upper endoscopy findings
  • pre-operative cardiac consultation for risk stratification
  • evaluation by a sleep medicine specialist to identify risk factors for sleep apnea, with treatment as deemed appropriate

Exclusion Criteria:

  • current participation in another clinical trial that involves any investigational drug or device that would interfere with this study
  • Barrett's Esophagus, severe gastric paresis/atony, achalasia, neoplasm or other complications discovered during preoperative esophago-gastro-duodonoscopy.
  • revisional surgery
  • conversion to open procedure
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ViSiGi
Utilization of ViSiGi calibration tube
Device: Utilization of ViSiGi calibration tube
Utilization of ViSiGi calibration tube
Other Names:
  • ViSiGi 3D
ACTIVE_COMPARATOR: Usual standard of care
Usual non suction Bougie
Device: Usual non suction Bougie
Usual non suction Bougie

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficasy
Time Frame: 3 months
This exploratory study will investigate the gastric delineation ability, general safety and efficacy of the ViSiGi™ Calibration Tube System along with the regular bougie in LSG patients over a six- to twelve-month period. Descriptive outcomes will be reported, with no formal sample size calculation in light of the exploratory study design.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital and Health Network, Pennsylvania

Collaborators

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLHN2013-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed;

Clinical Trials on Utilization of ViSiGi calibration tube

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