Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04876846 |
| Other study ID # |
GEN 3 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 24, 2021 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Raydiant Oximetry, Inc. |
| Contact |
Laura Kemp |
| Phone |
4083751465 |
| Email |
laurakemp[@]raydiantoximetry.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 five images taken at the locations
indicated on Figure 1. Depth to fetus will be recorded along with measurement of all
distinctive layers. 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
Oximetry Sensing System (ROSS) device is a non-invasive fetal pulse oximeter that measures
fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared
spectroscopy. The combination of these two devices makes up the Raydiant Oximetry GEN 3
device. This GEN 3 device will be positioned on the maternal abdomen of women volunteers in
the late 3rd trimester. This sensor will measure light scattering and absorption for a period
of about 10-20 minutes. A second measurement may be obtained for an additional site on the
maternal abdomen. The Sponsor anticipates this study will require about 6-12 months to enroll
all study subjects at all study sites, and another month to complete primary analyses.
