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NCT03621475 · ClinicalTrials.gov registry record · Phase 1
Novel Arm Restraint in the Intensive Care Unit
A Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03621475: Completed Phase 1 study, sponsored by University of Vermont.
NCT03621475 is a Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03621475, a Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.
Primary Outcome
Safety will be measured by the number (i.e. \< 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.
Interventions
- DEVICE Novel restraint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-04-15 |
| Phase | Phase 1 |
What the finished NCT03621475 record still lists
NCT03621475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Novel restraint is the first listed.
NCT03621475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03621475 about?
NCT03621475 is a clinical study titled "Novel Arm Restraint in the Intensive Care Unit". The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.
What is the current status of trial NCT03621475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-10-01. Estimated completion is 2019-04-15.
What interventions are being tested in trial NCT03621475?
The interventions under investigation include: Novel restraint (DEVICE).
Who is sponsoring clinical trial NCT03621475?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03621475's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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