Investigating how a gastric electrical stimulator works for treating gastroparesis
Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
This study is trying to understand how a gastric electrical stimulator helps some people with severe gastroparesis feel better while others do not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06582576 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the mechanisms of action of a surgically implanted gastric electrical stimulator in patients with drug-refractory gastroparesis. It will enroll up to thirty individuals, dividing them into responders and non-responders based on their symptom improvement. The study will assess potential central effects in the brain and peripheral effects in the stomach related to gastric electrical stimulation. The goal is to better understand why some patients experience significant symptom relief while others do not.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with an implanted gastric electrical stimulator for treating gastroparesis.
Not a fit: Patients who have had previous surgeries on the vagus nerve or those with implanted cardiac devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from gastroparesis.
How similar studies have performed: While gastric electrical stimulation has shown efficacy in symptom relief, the specific mechanisms being investigated in this study have not been extensively explored in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Where this trial is running
Aarhus N
- Department of hepatology and gastroenterology, Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Ditte Kornum, MD
- Email: Dittiver@rm.dk
- Phone: 40517858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.