Medtronic Enterra II Neurostimulator

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Nausea Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Treating Self Reported Nausea and Vomiting using Enterra II during procedure

Time frame: Up to 30 days

Using Enterra II system to prevent self reported Nausea and vomiting during a procedure

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2025
Study completion: 2025
First posted: Jan 22, 2024
Registry last updated: Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation