Status:
ENROLLING_BY_INVITATION
Medtronic Enterra II Neurostimulator
Lead Sponsor:
Methodist Health System
Conditions:
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Detailed Description
Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. These com...
Eligibility Criteria
Inclusion
- chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 14 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06215547
Start Date
September 15 2015
End Date
September 14 2025
Last Update
November 20 2024
Active Locations (1)
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1
Methodist Richardson Medical Center
Richardson, Texas, United States, 75082