Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Part of paid clinical trials in Shreveport, Louisiana.
- Sponsor
- Raydiant Oximetry, Inc.
- Study ID
- NCT07296419
- Status
- Recruiting
Conditions
- Fetal Acidemia
- Fetal Hypoxia
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Fetal Pulse Oximetery — DEVICETwo fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.
Study Details
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.
Key Dates
- Start date
- Dec 8, 2025
- Status verified
- Dec 2025
- Primary completion
- Mar 31, 2026
- Completion
- Apr 30, 2026
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Dual Sensor RecipientsWomen in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.
Primary Outcome Measure
Rate of device-related adverse events [ Time Frame: Periprocedural ]
Central Contacts
- Shannon Phillips, RN, BSN318-675-7207
- Chelsie Liegey, LPC, RN318-675-7064
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| LSU Health Science Center-Shreveport | Shreveport | Louisiana | 71101 | Chelsie Liegey, RN Perry S Barrilleaux, MD (PRINCIPAL_INVESTIGATOR) |
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