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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06405984
The ClinicalTrials.gov registry entry for NCT06405984 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Raydiant Oximetry, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fetal Oxygenation Measurements is the first listed.
NCT06405984 reports 0 study locations.
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.
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