Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

NCT04081623 | Terminated FDA Device

• 1 other identifier: ROSS Gen 2
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This project is set up to advance and integrate the 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,

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

• Fetal signal integrity

  Integrity of the fetal signal relative to background maternal signal and biologic/electronic noise, and related to fetal position, presentation and the depth of the fetus from maternal skin.

  During NST, BPP, or active labor

Study Arms (2)

Clinic

This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)

Device: Raydiant Oximetry Sensing System

Labor and Delivery

This group is in active labor.

Device: Raydiant Oximetry Sensing System

Interventions

Raydiant Oximetry Sensing System DEVICE

The investigational device is used to record fetal pulse signals.

Also known as: ROSS

Clinic; Labor and Delivery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor

You may qualify if:

• Pregnant women with singleton pregnancies, vertex presentation
• Age ≥ 18 years
• Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
• Healthy women ≥ 37 weeks in labor
• Vertex presentation

You may not qualify if:

• Age \<18 years
• Multiple gestation ( twins, triplets)
• Presentation other than vertex
• \< 28 weeks of gestation

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 9, 2019
• Study Start: April 16, 2019
• Primary Completion: May 20, 2021
• Study Completion: June 8, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)