Fetus Pulse MonitoringNCT05853146
Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
An observational study of Fetus Pulse Monitoring, run by Oxitone Medical Ltd..
Trial summary
The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device. Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetus Pulse Monitoring
- What is being tested?
- Oxitone 1000M
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Sep 2023
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women in the third trimester of pregnancy with one fetus.
Who may be able to join
- Healthy individuals between the age of 18-50
Who cannot join
- Clotting disorders, diabetes, currently taking psychotropic medications
About this study
The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.
Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.
Read more
Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.
Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.
- Conditions
- Fetus Pulse Monitoring
- Being tested
- Oxitone 1000M
- Keywords
- fetus, pulse, monitoring, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxitone 1000MDevice
World's First FDA-cleared Wrist-Sensor Pulse Oximetry Monitor
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Healthy women in their third trimester of pregnancy with one fetus Receives: Device: Oxitone 1000M |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetus pulse
fetus pulse calculated by a new algorithm
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study startMay 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetus Pulse MonitoringStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxitone Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853146
- Sponsor's protocol ID
- 0262-22
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
- ClinicalTrials.gov ID
- NCT05853146
- Acronym / sponsor ID
- 0262-22
- Conditions
- Fetus Pulse Monitoring
- Keywords
- fetus, pulse, monitoring, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oxitone Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 10 May 2023 (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.
The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.
Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.
Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.
Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Device: Oxitone 1000MHealthy women in their third trimester of pregnancy with one fetus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women in the third trimester of pregnancy with one fetus.
Key inclusion criteria (1 listed)
- Healthy individuals between the age of 18-50
Key exclusion criteria (1 listed)
- Clotting disorders, diabetes, currently taking psychotropic medications
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 |
|---|---|---|
| Oxitone 1000MWorld's First FDA-cleared Wrist-Sensor Pulse Oximetry Monitor | Device | pregnant women |
Primary outcome
fetus pulse
Time frame: through study completion, an average of 1 year
fetus pulse calculated by a new algorithm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Related trials for Fetus Pulse Monitoring
Recruiting
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Sudden Unexplained Infant Death, Apnea of Newborn
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetus Pulse Monitoring, run by Oxitone Medical Ltd..
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 1 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
fetus pulse (time frame: through study completion, an average of 1 year). 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 10 May 2023.