Medtronic Enterra II Neurostimulator

Status unconfirmed · Not applicable

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT06215547

Run by

Methodist Health System

People needed

500

Starts

2015-09-15

Expected to finish

2025-09-14

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Methodist Richardson Medical Center — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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