An interventional study of GEN 3 Monitoring of Fetus in Fetal Hypoxia, sponsored by Raydiant Oximetry, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by Raydiant Oximetry, Inc. · Not applicable, Interventional, and Device feasibility
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.
This is a prospective, observational, non-significant risk study. The study involves using non-invasive devices that measure fetal depth and tissue light scattering on the maternal abdomen. Ultrasound assessment will be performed, and multiple images taken at various locations on the abdomen. All images will be captured with minimal probe pressure applied to allow accurate ascertainment of depth. Images will be anonymized, and all study data will be coded with a unique identifier. Key maternal descriptive statistics will be recorded from the medical record including BMI, height, weight (kg), parity, age and gestational age.
The ISS device is a customized commercial frequency domain oximeter (Imagent, ISS Inc.; http://www.iss.com/biomedical/instruments/imagent.html) with multiple laser sources and multiple detectors. This instrument is safe, uses non-ionizing radiation.
The Raydiant Lumerah device is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device will be positioned on the maternal abdomen of women volunteers in the late 3rd trimester.
23 studies on the registry are indexed under Fetal Hypoxia; 6 are open to participants now.
This study's enrollment of 9 is below the median of 145 across 18 interventional studies indexed under Fetal Hypoxia.
Browse Fetal Hypoxia studies →Raydiant Oximetry, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: GEN 3 Monitoring of Fetus
Measurement of tissue light scatter in the "body in body" during late term pregnancy and evaluation of signal integrity
Fetal Signal
Correlation of the fetal doppler signal with the ROSS device optional fetal signal.
Time frame: After 36 weeks of pregnancy
Plan to share: No — The data are specific to this device only.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Raydiant Oximetry, Inc.