Medtronic Enterra II Neurostimulator

Not Applicable

• Conditions: Gastroparesis
• Interventions: Device: Enterra HDE

• Registration Number: NCT06215547
• Lead Sponsor: Methodist Health System

Brief 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

Study Timeline

• Study Start: 2015-09-15
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-09-14
• Study Completion: 2025-09-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Exclusion Criteria

• Organ transplant
• Organic obstruction
• Pseudo-obstruction
• Prior gastric surgery
• Scleroderma
• Amyloidosis
• History of seizures
• Peritoneal or unstable dialysis
• Chemical dependency
• Pregnancy
• Primary eating or swallowing disorders
• Psychogenic vomiting
• Implanted electronic medical devices
• Age < 18 or > 70 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Medtronic Enterra II Model 37800 Neurostimulator	Enterra HDE	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 Measures

Name	Time	Method
Treating Self Reported Nausea and Vomiting using Enterra II during procedure	Up to 30 days	Using Enterra II system to prevent self reported Nausea and vomiting during a procedure

Trial Locations

Locations (1)

Methodist Richardson Medical Center; 🇺🇸 Richardson, Texas, United States