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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: Clinical Trial NA study, sponsored by Medical College of Wisconsin.
NCT04721171 is a NA study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Abdominal pain will be assessed through Visual Analog Scale with the score of ranging from 0 to 10, with 0 being the least and 10 being the worst pain.
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 |
Why NCT04721171 stopped before completion
NCT04721171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which The Bridge device is the first listed.
NCT04721171 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04721171's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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