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Neurostimulator

The Medtronic Enterra II Model 37800 Neurostimulator for Gastroparesis

N/A

Waitlist Available

Led By Jenna L Wishnew, MD

Research Sponsored by Methodist Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

Study Summary

This trial is testing a medical device that has been approved for use in treating chronic nausea and vomiting caused by a condition called gastroparesis, which can be caused by diabetes or unknown reasons.

Who is the study for?

This trial is for adults aged 18 to 70 with severe, ongoing nausea and vomiting due to gastroparesis that hasn't improved with medication. It's not suitable for those who've had organ transplants, gastric surgery, certain other medical conditions like scleroderma or amyloidosis, seizures, are on dialysis, pregnant women, or individuals with eating disorders.Check my eligibility

What is being tested?

The Medtronic Enterra II Neurostimulator (Enterra HDE) is being tested. This device is approved in the U.S. specifically for treating chronic nausea and vomiting caused by gastroparesis when medications don't work.See study design

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risk from surgery, possible interference with other electronic devices in the body if present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe, ongoing nausea and vomiting due to slow stomach emptying, and I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treating Self Reported Nausea and Vomiting using Enterra II during procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: The Medtronic Enterra II Model 37800 NeurostimulatorExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor

152 Previous Clinical Trials

4,825,133 Total Patients Enrolled

Jenna L Wishnew, MDPrincipal InvestigatorMethodist Richardson Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to partake in this experimental study?

"In order to be eligible for enrollment, individuals must have a diagnosis of gastroparesis and fall within the age range of 18 to 70. The trial aims to recruit approximately 500 participants."

Answered by AI

Are participants currently being enrolled in this clinical trial?

"Apologies for the incorrect information. According to clinicaltrials.gov, this particular trial is not actively recruiting participants at present. The study was initially posted on September 15th, 2015 and was last updated on January 16th, 2024. However, it's worth noting that there are currently 38 other ongoing trials actively seeking participants."

Answered by AI

Is the age restriction for participation in this study limited to individuals under 35 years of age?

"To be eligible for enrollment in this trial, patients must fall within the age range of 18 to 70. Furthermore, there are separate studies available for individuals under the age of 18 (consisting of 4 studies) and those over the age of 65 (comprising 35 studies)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Medtronic Enterra II Neurostimulator

2015. "Medtronic Enterra II Neurostimulator". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215547.

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