Evaluation of the ViSiGiTM Calibration System

Phase 1

• 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: Device: Utilization of ViSiGi calibration tube; Device: Usual non suction Bougie

• Registration Number: NCT02008825
• Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

Brief 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.

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 Timeline

• Study First Submitted: 2013-11-07
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11
• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ViSiGi	Utilization of ViSiGi calibration tube	Utilization of ViSiGi calibration tube
Usual standard of care	Usual non suction Bougie	Usual non suction Bougie

Primary Outcome Measures

Name	Time	Method
Efficasy	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.

Trial Locations

Locations (1)

Saint Luke's University and Health Network; 🇺🇸 Allentown, Pennsylvania, United States