Fetal DistressNCT04081623
Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
An observational study of Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
Trial 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, Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress
- What is being tested?
- Raydiant Oximetry Sensing System
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 8 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Multiple gestation ( twins, triplets)
- Presentation other than vertex
- < 28 weeks of gestation
Trial locations and contacts
1 site in 1 country.
About this study
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,
Read the detailed description
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.
- Conditions
- Fetal Distress
- Being tested
- Raydiant Oximetry Sensing System
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raydiant Oximetry Sensing SystemDevice
Also called ROSS
The investigational device is used to record fetal pulse signals.
| Study group | Role | What they receive |
|---|---|---|
| Clinic | This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP) Receives: Device: Raydiant Oximetry Sensing System | |
| Labor and Delivery | This group is in active labor. Receives: Device: Raydiant Oximetry Sensing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During NST, BPP, or active labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start16 Apr 2019
- Primary completion20 May 2021
- Study completion8 Jun 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raydiant Oximetry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081623
- Sponsor's protocol ID
- ROSS Gen 2
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
- ClinicalTrials.gov ID
- NCT04081623
- Acronym / sponsor ID
- ROSS Gen 2
- Conditions
- Fetal Distress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Raydiant Oximetry, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Detailed description
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic | – | Device: Raydiant Oximetry Sensing SystemThis group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP) |
| Labor and Delivery | – | Device: Raydiant Oximetry Sensing SystemThis group is in active labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age <18 years
- Multiple gestation ( twins, triplets)
- Presentation other than vertex
- < 28 weeks of gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raydiant Oximetry Sensing SystemAlso: ROSSThe investigational device is used to record fetal pulse signals. | Device | Clinic, Labor and Delivery |
Primary outcome
Fetal signal integrity
Time frame: During NST, BPP, or active labor
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.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Distress, run by Raydiant Oximetry, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal signal integrity (time frame: During NST, BPP, or active labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.