Evaluation of the ViSiGiTM Calibration System

Study Overview
=================
Brief Summary
-----------------
We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will: 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; and 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.

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

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.

Intervention / Treatment
-----------------
* Device: Utilization of ViSiGi calibration tube
* Device: Usual non suction Bougie


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ViSiGi<br>Utilization of ViSiGi calibration tube | Device: Utilization of ViSiGi calibration tube<br>* Utilization of ViSiGi calibration tube<br>* Other names: ViSiGi 3D;|
| Active Comparator: Usual standard of care<br>Usual non suction Bougie | Device: Usual non suction Bougie<br>* Usual non suction Bougie<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficasy | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ViSiGi, Calibration tube, Sleeve gastrectomy