Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

NCT07296419 | Recruiting DMC FDA Device

• 1 other identifier: CP2555
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Acidemia; Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

• Rate of device-related adverse events

  Rate of device-related adverse events such as erythema or rash

  Periprocedural

Secondary Outcomes (2)

• Maternal Outcomes

  Periprocedural

• Neonatal Outcomes

  Periprocedural

Study Arms (1)

Dual Sensor Recipients

EXPERIMENTAL

Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.

Device: Fetal Pulse Oximetery

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.

Dual Sensor Recipients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women in labor
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing informed consent.
• Age \> 18 years.
• Gestational age \> 36 weeks.
• Singleton pregnancy.
• Vertex presentation,
• In latent or active labor,
• Category I or II tracings,
• Epidural anesthesia, and
• Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower.

You may not qualify if:

• Age \< 18 years.
• Gestational age \< 36 weeks
• Multiple gestation
• Nonvertex fetal presentation
• Suspected vasa previa
• Category III CTG tracing
• 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.

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

LSU Health Science Center-Shreveport

Shreveport, Louisiana, 71101, United States

RECRUITING

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Perry S Barrilleaux, MD

  Louisiana State University Health Shreveport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Phillips, RN, BSN

CONTACT

318-675-7207; shannon.phillips@lsuhs.edu

Chelsie Liegey, LPC, RN

CONTACT

318-675-7064

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: December 8, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)