Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03120325 · ClinicalTrials.gov registry record · NA
Vagal Nerve Stimulation for Gastroparesis
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT03120325: Clinical Trial NA study, sponsored by Stanford University.
NCT03120325 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120325, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment. There are 6 research visits Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout) Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study. The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase. Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.
Interventions
- DEVICE Vagal Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-08-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03120325
The ClinicalTrials.gov registry entry for NCT03120325 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vagal Nerve Stimulation is the first listed.
NCT03120325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03120325 about?
NCT03120325 is a clinical study titled "Vagal Nerve Stimulation for Gastroparesis". This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastr...
What is the current status of trial NCT03120325?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2017-03-01. Estimated completion is 2018-08-24.
What interventions are being tested in trial NCT03120325?
The interventions under investigation include: Vagal Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03120325?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.