Digestive Health Clinical Trials
Gastric Electrical Stimulation using Enterra™ Therapy for Clinical Use in Patients with Refractory Nausea and Vomiting and Gastroparesis
What is the purpose of this study?
The EnterraTM therapy is a medical device developed by Enterra Medical, Inc., (Saint Louis Park, MN) to treat refractory nausea and vomiting due to gastroparesis.
Eligibility
The patients will have documented gastroparesis based on a nuclear medicine solid-phase gastric emptying test (EggBeaters test meal). Delayed emptying is confirmed if 60% or > of the meal is retained at 2 hours and if 10% or > retention occurs at 4 hours. A commercially available breath test for gastroparesis is also available. In addition, upper endoscopy is normal and other causes of chronic nausea and vomiting have been excluded in these patients.
Patients who are candidates for Enterra therapy are considered refractory to medications if they have failed at least two classes of drugs: e.g. prokinetic agents (e.g. metoclopramide, erythromycin, domperidone) and anti-emetic agents (e.g. phenergan, compazine, ondansetron) for nausea and vomiting symptoms associated with gastroparesis.
Finally, patients must be considered good surgical candidates from physical and mental viewpoints as assessed by their physician and surgeon.
Patients who are considered poor surgical candidates from physical and mental viewpoints as assessed by their physician and surgeon are excluded.
Patients who require diathermy treatments or abdominal or chest MRIs are excluded due to risks to heat related tissue injury and damage to the device. Patients with eating disorders, narcotic or opioid addiction or cannabis hyperemesis should not have Enterra Therapy. Patients aged less than 18 or older than 70 years are excluded.
Where can I participate?
- Disease Type/ConditionGastroparesis
- Principal InvestigatorChristy M. Dunst, MD
- Age GroupAdult
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
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