Status:
RECRUITING
Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aalborg University Hospital
Aarhus University Hospital
Conditions:
Gastroparesis
Vomiting
Eligibility:
All Genders
18+ years
Brief Summary
Background: Gastric electrical stimulation applied by a surgically implanted device effectively alleviates upper gastrointestinal symptoms in the majority of individuals with medically refractory gast...
Eligibility Criteria
Inclusion
- Age 18 and above
- Able to read and understand Danish
- Have an implanted gastric electrical stimulator for treating gastroparesis
- Answering 0 or 1 (non-responders) or 3 or 4 (responders) on the Likert scale describing the symptom improvement gained by gastric electrical stimulation.
- Personally signed and dated the informed consent documents ("Informeret samtykke") indicating that the patient has been informed of all pertinent aspects of the trial
- Are willing and able to comply with the scheduled visit and trial procedures
Exclusion
- Previous surgery on the vagus nerve, including cervical vagotomy
- Prior thoracic, abdominal or brain surgeries that, in the opinion of the investigator, could limit data collection or interpretation.
- Previous diagnosis or history of orthostatic intolerance, e.g. POTS, neurocardiogenic syncope, orthostatic hypotension or autonomic dysfunction.
- Patients with an implanted cardiac device (e.g. pacemaker, CRT, etc.) or vagal nerve stimulator (VNS).
- History of neurological disease that, in the opinion of the investigator, could limit data collection or interpretation.
- Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results
Key Trial Info
Start Date :
September 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06582576
Start Date
September 2 2024
End Date
October 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Department of hepatology and gastroenterology, Aarhus University Hospital
Aarhus N, Denmark, 8200