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Medtronic Enterra II Neurostimulator
Sponsor: Methodist Health System
Summary
Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2015-09-15
Completion Date
2025-09-14
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
Enterra HDE
Instructions for use Implanting physicians should have experience in the surgical and/or implantation techniques for the Enterra II system, operational and functional characteristics of the Enterra II system, 12 English 37800 2014-03 and experience in the continued management of patients by stimulation parameter adjustment. Physicians may contact Medtronic before prescribing or implanting an Enterra II system for the first time, and request a referral to a physician experienced in the use of the Enterra II system. Implanting physicians should be thoroughly familiar with all product labeling. Cautions: * When using sharp instruments near the neurostimulator, be extremely careful to avoid nicking or damaging the case, the insulation, or the connector block. Damaging the neurostimulator may require surgical replacement. * Do not use saline or other ionic fluids at connections, which could result in a short circuit
Locations (1)
Methodist Richardson Medical Center
Richardson, Texas, United States