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Enterra Therapy Gastric Stimulation System

2014-07-24 14:19:54 | BioPortfolio

Summary

Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.

In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven.

Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.

Study Design

Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastroparesis

Intervention

Enterra Therapy Gastric Stimulator

Location

Columbia University College of Physicians and Surgeons
New York
New York
United States
10032

Status

Terminated

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:54-0400

Clinical Trials [1059 Associated Clinical Trials listed on BioPortfolio]

Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. ...

Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis

The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when ...

Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral endoscopi...

Naloxegol for Opioid-Related Gastroparesis

The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of gastroparesis; 2...

PubMed Articles [9706 Associated PubMed Articles listed on BioPortfolio]

Gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis: a multicenter international experience.

 Gastroparesis is a difficult-to-treat motility disorder with a poor response to medical therapy. Gastric peroral endoscopic pyloromyotomy (G-POEM) has been offered as a novel therapy in the treatme...

The effect of extracorporeal low-energy shockwave on diabetic gastroparesis in a rat model.

Delayed gastric emptying occurs in more than 50% of chronic diabetic patients and this is associated with significant impairments in quality of life. Traditional therapy for delayed gastric emptying h...

Gastric PerOral Endoscopic Pyloromyotomy Reduces Symptoms, Increases Quality of Life, and Reduces Healthcare Usage For Patients With Gastroparesis.

Gastric per-oral endoscopic pyloromyotomy (GPOEM) is becoming a promising treatment option for patients with refractory gastroparesis. We aimed to systematically assess the efficacy of GPOEM and its e...

Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function.

 Gastroparesis is a functional disorder with a variety of symptoms that is characterized by delayed gastric emptying in the absence of mechanical obstruction. A recent series of retrospective studie...

Diabetic Gastroparesis: Principles and Current Trends in Management.

This article is a comprehensive review of diabetic gastroparesis, defined as delayed or disordered gastric emptying, including basic principles and current trends in management. This review includes s...

Medical and Biotech [MESH] Definitions

Chronic delayed gastric emptying. Gastroparesis may be caused by motor dysfunction or paralysis of STOMACH muscles or may be associated with other systemic diseases such as DIABETES MELLITUS.

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

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.

A synthetic methylprostaglandin E1 analog that reduces gastric acid secretion and enhances the gastric mucus-bicarbonate barrier. It is effective in the therapy of gastric ulcers and gives significant protection against NSAID-induced gastric mucosal damage. The drug also prevents cyclosporin A-induced damage to endocrine and exocrine pancreatic secretions. It shows a low order of acute toxicity and there is no evidence of embryotoxicity, fetotoxicity, teratogenicity, or mutagenicity in animal studies.

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