Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

• ClinicalTrials.gov Identifier: NCT04876846
• Recruitment Status: Recruiting
• First Posted: May 7, 2021
• Last Update Posted: November 26, 2021
• Sponsor: Raydiant Oximetry, Inc.
• Information provided by (Responsible Party): Raydiant Oximetry, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Fetal Hypoxia	Device: GEN 3 Monitoring of Fetus	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Generation 3
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
• Actual Study Start Date: April 24, 2021
• Estimated Primary Completion Date: January 31, 2022
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

Arm	Intervention/treatment
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.	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

Outcome Measures

Primary Outcome Measures :

1. Fetal Signal [ Time Frame: After 36 weeks of pregnancy ]
   Correlation of the fetal doppler signal with the ROSS device optional fetal signal.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
2. Age > 18 years
3. Willing to come in for testing outside of routine business hours (including Saturdays)

Exclusion Criteria:

1. Age <18
2. Multiple gestation (twins, triplets)
3. Presentation other than vertex or breech
4. < 36 weeks of gestation

Contacts and Locations

Contacts

Contact: Laura Kemp; 4083751465; laurakemp@raydiantoximetry.com

Contact: Russ Delonzor; 9257851163; russdelonzor@raydiantoximetry.com

Locations

United States, California

Yaron Friedman, MD, Inc.; Recruiting

Walnut Creek, California, United States, 94598

Contact: Julie Pasqualy, PA 925-674-2580

Sponsors and Collaborators

Raydiant Oximetry, Inc.

Investigators

• Study Director: Mark Rosen, MD; Raydiant Oximetry

More Information

• Responsible Party: Raydiant Oximetry, Inc.
• ClinicalTrials.gov Identifier: NCT04876846
• Other Study ID Numbers: GEN 3
• First Posted: May 7, 2021
• Last Update Posted: November 26, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The data are specific to this device only.

• 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

Additional relevant MeSH terms:

Fetal Hypoxia; Hypoxia; Signs and Symptoms, Respiratory; Fetal Diseases; Pregnancy Complications