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NCT06405984 · ClinicalTrials.gov registry record · Early Phase 1
Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
A Early Phase 1 study, sponsored by Raydiant Oximetry.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
NCT06405984: Completed Early Phase 1 study, sponsored by Raydiant Oximetry.
NCT06405984 is a Early Phase 1 study that has completed, run by Raydiant Oximetry. The registered enrollment target is 35 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06405984, a Early Phase 1 study, has completed, sponsored by Raydiant Oximetry.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.
Primary Outcome
Prototype device feasibility of detecting reflected optical signals at different wavelengths ("colors") from the fetus
Interventions
- DEVICE Fetal Oxygenation Measurements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-04-15 |
| Est. Completion | 2025-10-17 |
| Phase | Early Phase 1 |
What the finished NCT06405984 record still lists
NCT06405984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 1 intervention - of which Fetal Oxygenation Measurements is the first listed.
NCT06405984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06405984 about?
NCT06405984 is a clinical study titled "Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE". The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In t...
What is the current status of trial NCT06405984?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2024-04-15. Estimated completion is 2025-10-17.
What interventions are being tested in trial NCT06405984?
The interventions under investigation include: Fetal Oxygenation Measurements (DEVICE).
Who is sponsoring clinical trial NCT06405984?
This trial is sponsored by Raydiant Oximetry, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06405984's enrollment target sits among peer trials
35 735th of 2000 higher than 1,254 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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