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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastroparesis
• Intervention / Treatment: Device: Enterra HDE

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75082
      • Methodist Richardson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treating Self Reported Nausea and Vomiting using Enterra II during procedure	Using Enterra II system to prevent self reported Nausea and vomiting during a procedure	Up to 30 days

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Sachin Kukreja, MD, Methodist Heath System

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Estimated): September 14, 2025
• Study Completion (Estimated): September 14, 2025

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: nausea; vomiting
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: Enterra HDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No at this moment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No