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 — DEVICE
    Two 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 Recipients
    Women 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, BSN
    318-675-7207
  • Chelsie Liegey, LPC, RN
    318-675-7064

Locations (1)

FacilityCityStateZIPSite coordinators
LSU Health Science Center-ShreveportShreveportLouisiana71101
Shannon Phillips, RN
318-675-7207
Chelsie Liegey, RN
Perry S Barrilleaux, MD (PRINCIPAL_INVESTIGATOR)

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