Trans-abdominal Fetal Pulse Oximetry

• Sponsor: Raydiant Oximetry, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05147584
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Condition or Disease	Intervention/Treatment	Phase
Fetal Hypoxia; Fetal Distress; Fetal Acidemia; Fetal or Neonatal Effect of Complication of Labor	Device: Dual fetal oxygen sensors	N/A

Detailed Description

Raydiant Oximetry, Inc. is developing a novel and non-invasive fetal pulse oximetry device to fundamentally improve how fetuses are monitored during labor. The Raydiant Oximetry Sensing System (Lumerah) is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah performs its measurements without the requirement for transvaginal placement and its associated risks. Lumerah is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation which is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The severe consequences associated with newborn metabolic acidosis and the lack of availability of an effective tool to support its early diagnosis led to the development of Lumerah.

In this study, women in labor will be simultaneously monitored with proven (previously FDA-approved) technology as a "ground truth". These women will be simultaneously monitored with both an external and internal oxygen sensor. Obstetric health-care providers are blinded to oximetry data presented by both devices; therefore, clinical decisions regarding interventions are made based on the standard factors, including cardiotocography. The primary efficacy analysis will be performed retrospectively by comparing data of fetal oxygenation displayed and recorded by both devices. Results of either the Lumerah external sensor or the internal sensor will not be used to guide or alter patient management.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a prospective, investigator-blinded study that is for data collection only. The primary purpose is to verify accuracy during the training of the algorithm by comparing the external sensor to a known internal sensor.This is a prospective, investigator-blinded study that is for data collection only. The primary purpose is to verify accuracy during the training of the algorithm by comparing the external sensor to a known internal sensor.
• Masking: None (Open Label)
• Masking Description: Results of either the external sensor or the internal sensor will not be shown to the subject, the care provider, or the investigator and will not be used to guide or alter patient management. The "outcomes assessor" will review the subject CTG and sensor data retrospectively.
• Primary Purpose: Other
• Official Title: Trans-abdominal Fetal Pulse Oximetry: PILOT 1
• Actual Study Start Date: Jul 18, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional/Observational The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively.	Device: Dual fetal oxygen sensors; Placement of both internal and external fetal oxygen sensors

Outcome Measures

Primary Outcome Measures

1. Fetal oxygen levels [During labor]

   Concurrence of internal and external fetal oxygen sensors

2. Adverse events [During labor]

   Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum. Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Willing and capable to provide informed consent

2. Age > 18 years

3. BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)

4. Gestational age > 36 weeks

5. Singleton pregnancy

6. Vertex presentation

7. Active labor

8. Category I or Category II tracings

9. Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower

Exclusion Criteria:

1. Age <18 years

2. BMI > 50 third trimester

3. Gestational age < 36 weeks

4. Multiple gestation

5. Nonvertex fetal presentation

6. Suspected vasa previa

7. Latent labor

8. Category III CTG tracing (i.e., need for immediate delivery)

9. Fetal anomalies and/or chromosomal disorders

10. Chorioamnionitis

11. Placenta Previa

12. History of HIV, Genital Herpes, or other infection precluding internal monitoring

13. Unable to provide informed consent (e.g., cognitively impaired)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical Branch (UTMB)	Galveston	Texas	United States	77555

Sponsors and Collaborators

• Raydiant Oximetry, Inc.

Investigators

• Study Director: Mark Rosen, MD, Raydiant Oximetry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raydiant Oximetry, Inc.
• ClinicalTrials.gov Identifier: NCT05147584
• Other Study ID Numbers: PILOT 1
• First Posted: Dec 7, 2021
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Fetal Hypoxia; Obstetric Labor Complications; Hypoxia; Fetal Distress

Study Results

No Results Posted as of Jul 22, 2022