Evaluation of the ViSiGiTM Calibration System
Launched by ST. LUKE'S HOSPITAL AND HEALTH NETWORK, PENNSYLVANIA · Dec 10, 2013
Trial Information
Current as of May 24, 2025
Unknown status
Keywords
ClinConnect Summary
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 inc...
Gender
ALL
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
About St. Luke's Hospital And Health Network, Pennsylvania
St. Luke's Hospital and Health Network, located in Pennsylvania, is a leading healthcare institution dedicated to providing high-quality medical services and advancing clinical research. With a commitment to patient-centered care and innovation, St. Luke's actively engages in clinical trials across various medical disciplines, contributing to the development of new therapies and treatment protocols. The organization emphasizes collaboration, integrity, and excellence, ensuring that all research initiatives align with the highest ethical standards and regulatory compliance. Through its robust clinical trial program, St. Luke's aims to enhance patient outcomes and improve healthcare delivery within the community and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Allentown, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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