NCT06215547

Medtronic Enterra II Neurostimulator

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. These components comprise the implantable portion of the Medtronic Enterra II system. The operation of the neurostimulator is supported by a clinician programmer. The neurostimulator (Figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system. A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer. System Components * Neurostimulator: Medtronic Enterra II Model 37800 * Controlling Devices: Medtronic Model 8840 Clinician Programmer with Model 8870 Application Card. Model 8527 Printer optional. * Lead: Medtronic Enterra Model 4351 Unipolar Lead

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2015-09-15
• Primary completion: 2025-09-14
• Completion: 2025-09-14
• First posted: 2024-01-22
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study