Neurostimulator for Gastroparesis

Recruiting in Palo Alto (17 mi)

Overseen byJenna L Wishnew, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Methodist Health System

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I have had surgery on my stomach before.

I have a history of seizures.

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

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Participant Groups

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.

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.