Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

Oxygen Deficiency Clinical Trial

Official title:

Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405984
• Other study ID #: CP2340
• Secondary ID: R44HD094486
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 15, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Raydiant Oximetry, Inc.
• Contact: Kristin Ayers, MPH
• Phone: 757.446.0529
• Email: ayerskl[@]evms.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

Description:

This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Willing and capable to provide informed consent

2. Age > 18 years

3. < 4 cm between maternal skin and fetal skin (determined by ultrasound)

4. Gestational age > 36 weeks

5. Singleton pregnancy

6. Vertex presentation

7. Active labor

8. Category I and Category II tracings, and

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

Exclusion Criteria:

1. Age < 18 years

2. Gestational age < 36 weeks

3. Multiple gestation

4. Nonvertex fetal presentation

5. Suspected vasa previa

6. Latent labor

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

8. Fetal anomalies and/or chromosomal disorders

9. Chorioamnionitis

10. Placenta Previa

11. History of HIV, Genital Herpes, or other infection precluding transvaginal monitoring

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

13. > 4 cm fetal depth (determined by Ultrasound),

14. Low anterior placenta, or

15. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures

Related Conditions & MeSH terms

• Fetal Complications
• Fetal Conditions
• Fetal Distress
• Fetal Hypoxia
• Hypoxia
• Labor (Obstetrics)--Complications
• Labor Fetal Anoxia
• Oxygen Deficiency

Intervention

Device:
• Fetal Oxygenation Measurements
The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.

Locations

Country	Name	City	State
United States	Sentara Norfolk General - Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Raydiant Oximetry, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of monitoring fetal signals.	Prototype device feasibility of detecting reflected optical signals at different wavelengths ("colors") from the fetus	During labor for up to 6 hours
Primary	Safety of the prototype device	Rate of adverse events and serious adverse events	Up to 72 hours post partum