Evaluation of the ViSiGiTM Calibration System

NCT ID: NCT02008825

Last Updated: 2013-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-05-31

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.

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.

Keywords

ViSiGi; Calibration tube; Sleeve gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ViSiGi

Utilization of ViSiGi calibration tube

Group Type: EXPERIMENTAL

Utilization of ViSiGi calibration tube

Intervention Type: DEVICE

Utilization of ViSiGi calibration tube

Usual standard of care

Usual non suction Bougie

Group Type: ACTIVE_COMPARATOR

Usual non suction Bougie

Intervention Type: DEVICE

Usual non suction Bougie

Interventions

Utilization of ViSiGi calibration tube

Utilization of ViSiGi calibration tube

Intervention Type: DEVICE

Usual non suction Bougie

Usual non suction Bougie

Intervention Type: DEVICE

Other Intervention Names

ViSiGi 3D

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

St. Luke's Hospital and Health Network, Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Claros

Bariatric Section Chief and Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Luke's University and Health Network

Allentown, Pennsylvania, United States

Countries

United States

Central Contacts

Leonardo Claros, MD

Role: CONTACT

Phone: 4844262600

Email: Leonardo.Claros@sluhn.org

Facility Contacts

Leonardo Claros

Role: primary

References

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Reference Type: BACKGROUND

PMID: 26318 (View on PubMed)

Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. Laparoscopic sleeve gastrectomy--influence of sleeve size and resected gastric volume. Obes Surg. 2007 Oct;17(10):1297-305. doi: 10.1007/s11695-007-9232-x.

Reference Type: BACKGROUND

PMID: 18098398 (View on PubMed)

Abu-Gazala S, Donchin Y, Keidar A. Nasogastric tube, temperature probe, and bougie stapling during bariatric surgery: a multicenter survey. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):595-600; discussion 600-1. doi: 10.1016/j.soard.2011.08.017. Epub 2011 Aug 31.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21769286 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 6765053 (View on PubMed)

Kovaleva J, Peters FT, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 2013 Apr;26(2):231-54. doi: 10.1128/CMR.00085-12.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10683209 (View on PubMed)

Related Links

http://www.visigi.com

ViSiGi web site

Other Identifiers

SLHN2013-62

Identifier Type: -

Identifier Source: org_study_id