Pregnancy, AbdominalNCT03013842
Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
A study testing Raydiant Oximetry Sensor System in people with Pregnancy, Abdominal, run by University of California, Davis at 1 site in United States.
Trial summary
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate. We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy, Abdominal
- What is being tested?
- Raydiant Oximetry Sensor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 2 Aug 2017
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Greater than 36 weeks pregnant
- Singleton fetus
Who cannot join
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.
We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.
Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.
Read the detailed description
The study subject will have a brief trans-abdominal ultrasound examination.
3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.
It is anticipated that 6 months will be required to recruit, consent and study 25 participants.
- Conditions
- Pregnancy, Abdominal
- Being tested
- Raydiant Oximetry Sensor System
- Keywords
- pregnancy, fetal monitoring, fetal oximetry, fetal heart rate, pulse oximetry, near infrared spectroscopy
- Medical subject headings
- Pregnancy, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raydiant Oximetry Sensor SystemDevice
Also called ROSS
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Administration of Fetal Oximetry Probe | Experimental | Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women Receives: Device: Raydiant Oximetry Sensor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Photoplethysmogram
The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.
Measured: 6 months
Secondary outcomes (1)
Fetal Heart Rate
The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start12 Dec 2016
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Why it stopped: Principal Investigator no longer at Site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, AbdominalStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- CITRIS
- Responsible party
- Sponsor
- Investigators
- Neil Ray, MD, Principal investigator, 916-734-5028
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013842
- Sponsor's protocol ID
- 828902
- Status last verified
- Jan 2018
- First submitted
- 5 Dec 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
- ClinicalTrials.gov ID
- NCT03013842
- Acronym / sponsor ID
- 828902
- Conditions
- Pregnancy, Abdominal
- Keywords
- pregnancy, fetal monitoring, fetal oximetry, fetal heart rate, pulse oximetry, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator no longer at Site
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- CITRIS
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- 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.
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.
We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.
Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.
Detailed description
The study subject will have a brief trans-abdominal ultrasound examination.
3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.
It is anticipated that 6 months will be required to recruit, consent and study 25 participants.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Fetal Oximetry Probe | Experimental | Device: Raydiant Oximetry Sensor SystemAdministration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Greater than 36 weeks pregnant
- Singleton fetus
Key exclusion criteria (1 listed)
- Prisoners
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 Sensor SystemAlso: ROSSAdministration of Fetal Oximetry Probe on 36 weeks or greater pregnant women | Device | Administration of Fetal Oximetry Probe |
Primary outcome
Fetal Photoplethysmogram
Time frame: 6 months
The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.
1 secondary outcome
Fetal Heart Rate
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Principal Investigator no longer at Site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- 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.
Neil Ray, MD principal investigator
916-734-5028
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raydiant Oximetry Sensor System in people with Pregnancy, Abdominal, run by University of California, Davis 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 2 inclusion and 1 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 31 Jan 2018. 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: Principal Investigator no longer at Site). 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 Photoplethysmogram (time frame: 6 months). 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 31 Jan 2018.