Evaluation of the ViSiGiTM Calibration System

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

— ViSiGi  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02008825
• Other study ID #: SLHN2013-62
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 7, 2013
• Last updated: December 10, 2013
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: December 2013
• Source: St. Luke's Hospital and Health Network, Pennsylvania
• Contact: Leonardo Claros, MD
• Phone: 4844262600
• Email: Leonardo.Claros[@]sluhn.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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

Intervention

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

Locations

Country	Name	City	State
United States	Saint Luke's University and Health Network	Allentown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Hospital and Health Network, Pennsylvania	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

Péquignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6. — View Citation

Sanchez BS, Safadi BY, Kieran JA, Hsu GP, Brodsky JB, Curet MJ, Morton JM. Orogastric tube complications in laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006 Apr;16(4):443-7. — View Citation

Satiani B, Bonner JT, Stone HH. Factors influencing intraoperative gastric regurgitation: a prospective random study of nasogastric tube drainage. Arch Surg. 1978 Jun;113(6):721-3. — View Citation

Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 2000 Apr;10(2):215-32. Review. — View Citation

Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci. 1981 Jul;26(7 Suppl):60S-64S. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   ViSiGi web site