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NCT03519880 · ClinicalTrials.gov registry record · NA
A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT03519880: Clinical Trial NA study, sponsored by University of Michigan.
NCT03519880 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 5 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
NCT03519880, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Non-invasive ventilation (NIV) is an important therapy for patients with a number of neurological diseases. Specifically, NIV has been shown to be an effective treatment for people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is a fatal, non-curable, progressive disease of the motor neurons. However, due to changes in facial structure associated with the disease, many ALS patients find that traditional NIV masks don't fit well. In this study, investigators will perform a feasibility study on NIV mask interfaces which are custom designed for each ALS patient and then manufactured via 3D printing.
Primary Outcome
Average number of hours the custom NIV mask interface is used per night
Interventions
- DEVICE Custom Mask Interface
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2020-03-14 |
| Phase | NA |
Why NCT03519880 stopped before completion
NCT03519880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 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 Custom Mask Interface is the first listed.
NCT03519880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03519880 about?
NCT03519880 is a clinical study titled "A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects". Non-invasive ventilation (NIV) is an important therapy for patients with a number of neurological diseases. Specifically, NIV has been shown to be an effective treatment for people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is a fatal, non-curable, progressiv...
What is the current status of trial NCT03519880?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2017-03-14. Estimated completion is 2020-03-14.
What interventions are being tested in trial NCT03519880?
The interventions under investigation include: Custom Mask Interface (DEVICE).
Who is sponsoring clinical trial NCT03519880?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03519880's enrollment target sits among peer trials
5 1988th 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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