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NCT04100668 · ClinicalTrials.gov registry record · NA

Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies

A NA study, sponsored by Sensifree.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT04100668: Completed NA study, sponsored by Sensifree.

NCT04100668 is a NA study that has completed, run by Sensifree. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04100668, a NA study, has completed, sponsored by Sensifree.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter. The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.

Primary Outcome

BP waveform will be acquired form three sources (PPG, A-line and investigational device),data will be statistically analyzed to find the correlations between the different sources of BP waveform

Interventions

  • DEVICE GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
  • DEVICE Arrow® arterial catheterization kit (Teleflex)
  • DEVICE Sensifree's Alpha sensor

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-09-26
Est. Completion 2017-09-29
Phase NA
Sensifree

3 total trials

What the finished NCT04100668 record still lists

NCT04100668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor is the first listed.

NCT04100668 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04100668 about?

NCT04100668 is a clinical study titled "Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies". The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter. The study will be split into two phases: the first phase will collect data for morph...

What is the current status of trial NCT04100668?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2017-09-26. Estimated completion is 2017-09-29.

What interventions are being tested in trial NCT04100668?

The interventions under investigation include: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor (DEVICE), Arrow® arterial catheterization kit (Teleflex) (DEVICE), Sensifree's Alpha sensor (DEVICE).

Who is sponsoring clinical trial NCT04100668?

This trial is sponsored by Sensifree, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04100668's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 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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Source: ClinicalTrials.gov NCT04100668, the US trial registry maintained by the National Library of Medicine. NCT04100668 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.