Evaluation of the ViSiGiTM Calibration System
Status unconfirmed · Phase 1
Conditions studied: 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.
In brief
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.
Key facts
- Study ID
- NCT02008825
- Run by
- St. Luke's Hospital and Health Network, Pennsylvania
- People needed
- 22
- Starts
- 2014-01-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2013-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Saint Luke's University and Health Network — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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