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NCT05445206 · ClinicalTrials.gov registry record · NA
Clinical Validation Study for CPM Device
A NA study, sponsored by Analog Device.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05445206: Completed NA study, sponsored by Analog Device.
NCT05445206 is a NA study that has completed, run by Analog Device. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05445206, a NA study, has completed, sponsored by Analog Device.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 18 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For exercise 18, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.
Primary Outcome
Accuracy of CPM System calculated RR versus reference device reported as percentage of respiration rate error within +/- breath rates per minute. Acceptance for clinical utility is \>= 85%. Percentage of respiration rate error within ± 2bpm. Acceptance criteria for clinical utility is \>= 85%. The percentage of respiration rate within ± 2brpm was calculated by data points, regardless of its rate and breathing condition, which the CPM System did not screen, therefore reporting the numeric values.
Interventions
- DEVICE CardioPulmonary Management Device (CPM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2022-07-06 |
| Phase | NA |
What the finished NCT05445206 record still lists
NCT05445206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which CardioPulmonary Management Device (CPM) is the first listed.
NCT05445206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05445206 about?
NCT05445206 is a clinical study titled "Clinical Validation Study for CPM Device". This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to va...
What is the current status of trial NCT05445206?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-03-02. Estimated completion is 2022-07-06.
What interventions are being tested in trial NCT05445206?
The interventions under investigation include: CardioPulmonary Management Device (CPM) (DEVICE).
Who is sponsoring clinical trial NCT05445206?
This trial is sponsored by Analog Device, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05445206's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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