Medtronic Enterra II Neurostimulator

Gastroparesis Clinical Trial

Official title:

Medtronic Enterra II Neurostimulator

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06215547
• Other study ID #: Enterra HDE
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 15, 2015
• Est. completion date: September 14, 2025

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: September 14, 2025
• Est. primary completion date: September 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Richardson Medical Center	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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