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Neurostimulator

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

Must not have

Prior gastric surgery

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my stomach before.

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I have a history of seizures.

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I experience vomiting that's caused by stress or mental factors.

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I have a blockage in my intestine that acts like a physical blockage but isn’t one.

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I have scleroderma.

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I have been diagnosed with amyloidosis.

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I am on peritoneal or unstable dialysis.

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I have a condition that affects my ability to eat or swallow.

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I have had an organ transplant.

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I have a blockage in my body caused by physical matter.

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I am younger than 18 or older than 70.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treating Self Reported Nausea and Vomiting using Enterra II during procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met