Fetal HypoxiaNCT07296419
Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
A study testing Fetal Pulse Oximetery in people with Fetal Hypoxia and Fetal Acidemia, run by Raydiant Oximetry, Inc. at 1 site in United States.
Trial summary
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor. 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 Acidemia
- What is being tested?
- Fetal Pulse Oximetery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 of providing informed consent.
- Age > 18 years.
- Gestational age > 36 weeks.
- Singleton pregnancy.
- Vertex presentation,
- In latent or active labor,
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- Category I or II tracings,
- Epidural anesthesia, 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
- Category III CTG tracing
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- Fetal anomalies and/or chromosomal disorders
- Chorioamnionitis
- Placenta previa
- HIV, genital Herpes, or other infection precluding transvaginal monitoring
- Unable to provide informed consent (e.g., cognitively impaired)
- 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. Contact the study team or a site near you to ask about taking part.
Chelsie Liegey, LPC, RN contact
United States1 site, 1 recruiting
- Recruiting
LSU Health Science Center-Shreveport
Shreveport, Louisiana, 71101
Shannon Phillips, RN, 318-675-7207, shannon.phillips@lsuhs.edu
Chelsie Liegey, RN, chelsie.liegey@lsuhs.edu
About this study
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
Read the detailed description
The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.
In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.
- Conditions
- Fetal Hypoxia, Fetal Acidemia
- Being tested
- Fetal Pulse Oximetery
- Medical subject headings
- Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Pulse OximeteryDevice
Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Dual Sensor Recipients | Experimental | Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems. Receives: Device: Fetal Pulse Oximetery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device-related adverse events
Rate of device-related adverse events such as erythema or rash
Measured: Periprocedural
Secondary outcomes (2)
Maternal Outcomes
Maternal adverse outcomes such as chorioamnionitis or endometritis
Measured: Periprocedural
Neonatal Outcomes
Apgar Scores at 1 and 5 minutes
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Dec 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Raydiant Oximetry Data Collection System (DCS) generates waveforms representing fetal SpO2. In this study, the objective is to compare the waveforms generated by the DCS to the Nellcor N-400 actual fetal SpO2 values.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raydiant Oximetry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Perry S Barrilleaux, MD, Principal investigator, Louisiana State University Health Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296419
- Sponsor's protocol ID
- CP2555
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data is available to Raydiant Oximetry and LSU Study Staff only.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
- ClinicalTrials.gov ID
- NCT07296419
- Acronym / sponsor ID
- CP2555
- Conditions
- Fetal Hypoxia, Fetal Acidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Raydiant Oximetry, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Dec 2025 (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 objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
Detailed description
The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.
In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Raydiant Oximetry Data Collection System (DCS) generates waveforms representing fetal SpO2. In this study, the objective is to compare the waveforms generated by the DCS to the Nellcor N-400 actual fetal SpO2 values.
| Arm | Type | Receives |
|---|---|---|
| Dual Sensor Recipients | Experimental | Device: Fetal Pulse OximeteryWomen in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems. |
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 of providing informed consent.
- Age > 18 years.
- Gestational age > 36 weeks.
- Singleton pregnancy.
- Vertex presentation,
Key exclusion criteria (13 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 Pulse OximeteryTwo fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm. | Device | Dual Sensor Recipients |
Primary outcome
Rate of device-related adverse events
Time frame: Periprocedural
Rate of device-related adverse events such as erythema or rash
2 secondary outcomes
Maternal Outcomes
Time frame: Periprocedural
Neonatal Outcomes
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data is available to Raydiant Oximetry and LSU Study Staff only.
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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.
Chelsie Liegey, LPC, RN contact
Perry S Barrilleaux, MD principal investigator
Louisiana State University Health Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Pulse Oximetery in people with Fetal Hypoxia and Fetal Acidemia, 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 13 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: looking for participants now, as of the sponsor's last update on 22 Dec 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Phillips, RN, BSN (318-675-7207, shannon.phillips@lsuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device-related adverse events (time frame: Periprocedural). 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 22 Dec 2025.