Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional/Observational | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN 3 Monitoring of Fetus | Device | Measurement of tissue light scatter in the "body in body" during late term pregnancy and evaluation of signal integrity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Signal | Correlation of the fetal doppler signal with the ROSS device optional fetal signal. | After 36 weeks of pregnancy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Rosen, MD | Raydiant Oximetry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaron Friedman, MD, Inc. | Walnut Creek | California | 94598 | United States |
The data are specific to this device only.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005311 | Fetal Hypoxia |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |