Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the body in a body problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
• Age \> 18 years
• Willing to come in for testing outside of routine business hours (including Saturdays)
Locations
United States
California
Yaron Friedman, MD, Inc.
RECRUITING
Walnut Creek
Contact Information
Primary
Laura Kemp
laurakemp@raydiantoximetry.com
4083751465
Backup
Russ Delonzor
russdelonzor@raydiantoximetry.com
9257851163
Time Frame
Start Date: 2021-04-24
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 10
Treatments
Experimental: Interventional/Observational
The Gen 3 device will be positioned on the maternal abdomen to measure light scattering and absorption for a period of about 10-20 minutes. A second measurement may be obtained for a total of up to 40 minutes. Subject's end their participation in the study after that time period.
Related Therapeutic Areas
Sponsors
Leads: Raydiant Oximetry, Inc.