Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
Primary Purpose
Fetal Hypoxia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GEN 3 Monitoring of Fetus
Sponsored by
About this trial
This is an interventional device feasibility trial for Fetal Hypoxia
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Age <18
- Multiple gestation (twins, triplets)
- Presentation other than vertex or breech
- < 36 weeks of gestation
Sites / Locations
- Yaron Friedman, MD, Inc.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional/Observational
Arm Description
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.
Outcomes
Primary Outcome Measures
Fetal Signal
Correlation of the fetal doppler signal with the ROSS device optional fetal signal.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04876846
Brief Title
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
Official Title
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raydiant Oximetry, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Hypoxia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Generation 3
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional/Observational
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
GEN 3 Monitoring of Fetus
Intervention Description
Measurement of tissue light scatter in the "body in body" during late term pregnancy and evaluation of signal integrity
Primary Outcome Measure Information:
Title
Fetal Signal
Description
Correlation of the fetal doppler signal with the ROSS device optional fetal signal.
Time Frame
After 36 weeks of pregnancy
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Age <18
Multiple gestation (twins, triplets)
Presentation other than vertex or breech
< 36 weeks of gestation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Kemp
Phone
4083751465
Email
laurakemp@raydiantoximetry.com
First Name & Middle Initial & Last Name or Official Title & Degree
Russ Delonzor
Phone
9257851163
Email
russdelonzor@raydiantoximetry.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Rosen, MD
Organizational Affiliation
Raydiant Oximetry
Official's Role
Study Director
Facility Information:
Facility Name
Yaron Friedman, MD, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Pasqualy, PA
Phone
925-674-2580
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data are specific to this device only.
Learn more about this trial
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
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