Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed; Clinical Trial
— ViSiGiOfficial title:
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:
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Saint Luke's University and Health Network | Allentown | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
St. Luke's Hospital and Health Network, Pennsylvania | Boehringer Ingelheim |
United States,
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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 |