Medtronic Enterra II Neurostimulator

NCT06215547 | Enrolling By Invitation FDA Device

• 1 other identifier: Enterra HDE
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

nausea; vomiting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

The Medtronic Enterra II Model 37800 Neurostimulator

OTHER

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

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

The Medtronic Enterra II Model 37800 Neurostimulator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

Location

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Sachin Kukreja, MD

  Methodist Heath System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Medtronic - Enterra II Neurostimulator

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: January 22, 2024
• Study Start: September 15, 2015
• Primary Completion: September 14, 2025
• Study Completion: September 14, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)