Medtronic Enterra II Neurostimulator

Part of paid clinical trials in Richardson, Texas.

Sponsor
Methodist Health System
Study ID
NCT06215547
Status
Enrolling By Invitation

Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Enterra HDE — DEVICE
    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

Study Details

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 Dates

Start date
Sep 15, 2015
Status verified
Jul 2024
Primary completion
Sep 14, 2025
Completion
Sep 14, 2025

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: The Medtronic Enterra II Model 37800 Neurostimulator
    It is powered by a hermetically sealed hybrid cathode silver vanadium oxide (HCSVO) single-cell battery. To further protect the neurostimulator components from body fluids, the electronics and power source are hermetically sealed within an oval-shaped titanium shield. The neurostimulator case has an external insulating coating to prevent skeletal muscle stimulation at the neurostimulator implant site. An uninsulated area on one side of the neurostimulator (etched identification side) forms the indifferent electrode. The uninsulated side should be positioned away from muscle tissue. The neurostimulator has a self-sealing connector assembly with a corrosion-resistant titanium alloy body \& titanium setscrews. Securing the lead system requires the use of a torque wrench which is packaged with the neurostimulator.

Primary Outcome Measure

Treating Self Reported Nausea and Vomiting using Enterra II during procedure [ Time Frame: Up to 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Richardson Medical CenterRichardsonTexas75082-

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Methodist Richardson Medical Center· Richardson, TX

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