Fetal HypoxiaEarly Phase 1NCT06405984
Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
A Early Phase 1 study testing Fetal Oxygenation Measurements in people with Fetal Hypoxia and Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Hypoxia, Fetal Distress, Fetal Conditions
- What is being tested?
- Fetal Oxygenation Measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 17 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and capable to provide informed consent
- Age > 18 years
- < 4 cm between maternal skin and fetal skin (determined by ultrasound)
- Gestational age > 36 weeks
- Singleton pregnancy
- Vertex presentation
Show all 9Show fewer
- Active labor
- Category I and Category II tracings, and
- Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower
Who cannot join
- Age < 18 years
- Gestational age < 36 weeks
- Multiple gestation
- Nonvertex fetal presentation
- Suspected vasa previa
- Latent labor
Show all 15Show fewer
- Category III CTG tracing (i.e., need for immediate delivery)
- Fetal anomalies and/or chromosomal disorders
- Chorioamnionitis
- Placenta Previa
- History of HIV, Genital Herpes, or other infection precluding transvaginal monitoring
- Unable to provide informed consent (e.g., cognitively impaired)
- > 4 cm fetal depth (determined by Ultrasound),
- Low anterior placenta, or
- Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Sentara Norfolk General - Eastern Virginia Medical School
Norfolk, Virginia, 23510
About this study
Official title: Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study
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.
Read the detailed description
This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Conditions, Fetal Complications, Labor Fetal Anoxia, Labor (Obstetrics)--Complications
- Being tested
- Fetal Oxygenation Measurements
- Keywords
- fetal hypoxia, fetal distress, oxygen deficiency, labor fetal anoxia
- Medical subject headings
- Fetal Hypoxia, Fetal Distress, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Oxygenation MeasurementsDevice
The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.
| Study group | Role | What they receive |
|---|---|---|
| Laboring Women | Experimental | Women in labor who have consented to participation in the study. Receives: Device: Fetal Oxygenation Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of monitoring fetal signals.
Prototype device feasibility of detecting reflected optical signals at different wavelengths ("colors") from the fetus
Measured: During labor for up to 6 hours
Safety of the prototype device
Rate of adverse events and serious adverse events
Measured: Up to 72 hours post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Apr 2024
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, device feasibility study, based on convenience sampling.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raydiant Oximetry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405984
- Sponsor's protocol ID
- CP2340
- Other IDs
- R44HD094486
- Status last verified
- Oct 2025
- First submitted
- 3 Apr 2024
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a data collection study whereby data will be used for device development purposes. There is no plan to share these data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06405984
- Acronym / sponsor ID
- CP2340
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Conditions, Fetal Complications, Labor Fetal Anoxia, Labor (Obstetrics)--Complications
- Keywords
- fetal hypoxia, fetal distress, oxygen deficiency, labor fetal anoxia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Raydiant Oximetry, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, device feasibility study, based on convenience sampling.
| Arm | Type | Receives |
|---|---|---|
| Laboring Women | Experimental | Device: Fetal Oxygenation MeasurementsWomen in labor who have consented to participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and capable to provide informed consent
- Age > 18 years
- < 4 cm between maternal skin and fetal skin (determined by ultrasound)
- Gestational age > 36 weeks
- Singleton pregnancy
Key exclusion criteria (15 listed)
- Age < 18 years
- Gestational age < 36 weeks
- Multiple gestation
- Nonvertex fetal presentation
- Suspected vasa previa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Oxygenation MeasurementsThe Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only. | Device | Laboring Women |
Primary outcome
Feasibility of monitoring fetal signals.
Time frame: During labor for up to 6 hours
Prototype device feasibility of detecting reflected optical signals at different wavelengths ("colors") from the fetus
Safety of the prototype device
Time frame: Up to 72 hours post partum
Rate of adverse events and serious adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No. This is a data collection study whereby data will be used for device development purposes. There is no plan to share these data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fetal Oxygenation Measurements in people with Fetal Hypoxia and Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of monitoring fetal signals. (time frame: During labor for up to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.