- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02008825
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:
- 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.
Study Overview
Status
Unknown
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
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
- Name: Leonardo Claros, MD
- Phone Number: 4844262600
- Email: Leonardo.Claros@sluhn.org
Study Locations
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18104
- Saint Luke's University and Health Network
-
Contact:
- Leonardo Claros
- Phone Number: 484-426-2600
- Email: Leonardo.Claros@sluhn.org
-
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
|
Utilization of ViSiGi calibration tube
Other Names:
|
ACTIVE_COMPARATOR: Usual standard of care
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.
Collaborators
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
- 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. doi: 10.1001/archsurg.1978.01370180063008.
- 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.
- 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.
- Pequignot 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.
- 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. doi: 10.1381/096089206776327350.
- Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci. 1981 Jul;26(7 Suppl):60S-64S. doi: 10.1007/BF01300809.
- 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.
- Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 2000 Apr;10(2):215-32.
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.
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