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The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55.
The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55. Initially, a maximum of 150 patients will be followed for 12 months in a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of the IGS. All patients will be implanted with the IGS System and randomized to a control group (IGS OFF) or a treatment group (IGS ON). Both groups will follow a 500kcal/day-deficit diet (Appendix A) and participate in monthly support group meetings (Appendix E). The study will last for 24 months after randomization. The sponsor plans to submit a PreMarket Approval (PMA) application when all patients have completed 12 months of post-randomization follow-up. After 12 months from randomization, patients will continue to be followed monthly for another year, during which all patients will receive gastric electrical stimulation and the long-term efficacy and safety and maintenance of weight loss will be evaluated. After 24 months from randomization, all remaining patients will have the option to enter an extension study for an additional four years, during which the long-term efficacy and safety and maintenance of weight loss will continue to be evaluated.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
Transcend II Implantable Gastric Stimulator (IGS), Model 8848
Active, not recruiting
University of Pennsylvania
Published on BioPortfolio: 2014-07-24T14:25:14-0400
The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.
The purpose of this study is to determine the efficacy of of gastric bypass without gastric division as a treatment for morbid obesity
The main goal of this research project is to conduct a comparative effectiveness research study involving existing data in the PCORnet Common Data Model to provide accurate estimates of th...
Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to worsen. In the UK and worldwide the three most commonly performed operations are laparoscopic ...
The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice. Pacemakers, implantable car...
Gastroparesis (GP) is a chronic disorder of gastric motility with delayed gastric emptying. Gastric electrical stimulator (GES) implantation and Roux-en-Y gastric bypass (RYGB) are surgical options fo...
The early improvement in metabolic profile after sleeve gastrectomy (SG) indicates that the significant benefits of metabolic surgery are gastric in origin. We have previously demonstrated that devita...
The advent of the gastric organoid culture system has provided a new model to emulate native epithelial tissue in vitro. Gastric organoids grow from isolated epithelial stem cells and develop into thr...
To investigate the effects of semaglutide on fasting and postprandial glucose and lipid responses, and on gastric emptying.
A gastrointestinal peptide hormone of about 43-amino acids. It is found to be a potent stimulator of INSULIN secretion and a relatively poor inhibitor of GASTRIC ACID secretion.
Neuroendocrine cells in the glands of the GASTRIC MUCOSA. They produce HISTAMINE and peptides such as CHROMOGRANINS. ECL cells respond to GASTRIN by releasing histamine which acts as a paracrine stimulator of the release of HYDROCHLORIC ACID from the GASTRIC PARIETAL CELLS.
An inflatable device implanted in the stomach as an adjunct to therapy of morbid obesity. Specific types include the silicone Garren-Edwards Gastric Bubble (GEGB), approved by the FDA in 1985, and the Ballobes Balloon.
Types of artificial pacemakers with implantable leads to be placed at multiple intracardial sites. They are used to treat various cardiac conduction disturbances which interfere with the timing of contraction of the ventricles. They may or may not include defibrillating electrodes (IMPLANTABLE DEFIBRILLATORS) as well.
Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.
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