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NCT04721171 · ClinicalTrials.gov registry record · NA
Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.
A NA study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04721171 is a NA study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 4 participants.
The verdict
NCT04721171, a NA study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hypothesize that 2) PENFS reduces the length of stay (LOS), and improves patient satisfaction. We propose the following specific aim: Aim 1. Investigate the efficacy of PENFS compared to a sham in patients with CVS seen in the ED or in the clinic or hospitalized with an acute CVS episode. Objectives: 1. Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools. 2. Obviate or reduce the need for opioids. 3. Reduce the length of hospital stay and improve patient satisfaction. This approach will specifically address the current opioid problem using a novel, non-invasive neurostimulation therapy with proven efficacy for opioid withdrawal. Long-term, it may improve health care outcomes and significantly reduce overall health care costs.
Interventions
- DEVICE The Bridge device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-04-23 |
| Est. Completion | 2021-02-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721171
The ClinicalTrials.gov registry entry for NCT04721171 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which The Bridge device is the first listed.
NCT04721171 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04721171 about?
NCT04721171 is a clinical study titled "Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.". We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hy...
What is the current status of trial NCT04721171?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2019-04-23. Estimated completion is 2021-02-09.
What interventions are being tested in trial NCT04721171?
The interventions under investigation include: The Bridge device (DEVICE).
Who is sponsoring clinical trial NCT04721171?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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