Fetal Heart DisorderNCT03057665
Atomic Magnetometer for Fetal Biomagnetism
An observational study of Fetal Heart Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this study is the evaluation of an atomic magnetometer that is practical for human biomagnetism studies. The investigators have built a device that has the necessary sensitivity, and will be testing it on a small number of adults and approximately 30 healthy pregnant subjects, in preparation for beginning… 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 Heart Disorder
- What is being tested?
- Atomic Biomagnetometer
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 1 Apr 2019
- 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: Approximately 35 normal, nominally healthy adult volunteers (18 years or older) will be studied, including 30 pregnant women. The pregnant women will be healthy women with uncomplicated pregnancies. They will be studied at gestational ages 18-38 weeks, with studies terminating at 38 weeks or before. The non-pregnant adults will be either the PIs or other volunteers who do not have status relationship to the study investigators.
Who may be able to join
- The subjects will be asked if they consider themselves healthy, if they are able to sit or lie still for 5 minute periods during data acquisition, if they have large metal plates, screws, or devices, and if they are pregnant.
Who cannot join
- Participants who self-identify as being unhealthy or having complications with their pregnancy. In addition, vulnerable populations such as prisoners, veterans, individuals with impaired decision-making capabilities, and non-English speakers will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is the evaluation of an atomic magnetometer that is practical for human biomagnetism studies. The investigators have built a device that has the necessary sensitivity, and will be testing it on a small number of adults and approximately 30 healthy pregnant subjects, in preparation for beginning pre-clinical studies of high-risk pregnancies.
Read the detailed description
The goal of this study is evaluation of our atomic magnetometer for adult and fetal MCG studies. The investigators will assess the signal-to-noise and bandwidth performance under human acquisition conditions. They will also gain experience with the practical issues associated with making the measurements on human subjects.
The measurement sessions will take place in the magnetically shielded room in the UW Biomagnetism Laboratory, where similar studies have been made with SQUID detectors for more than 20 years, without incident. The room contains a bed and/or chair on which the subject may comfortably lie or sit.
The subject will remove all metal and magnetic objects (e.g. watches, glasses, jewelry, coins) and change into metal-free clothing. The subject will put on laser eye protection goggles. The subject will lie or sit on the patient bed in the magnetically shielded room with his or her chest (or stomach in the case of a pregnant mother) as close as possible to the magnetometer (typically 1 cm away), and will be monitored closely through a small opening in the shielded room to ensure comfort throughout the study. Positioning of the device with respect to the patient will be done by one of the researchers. In the case of pregnant women, an ultrasound will be taken to ascertain the position of the baby and facilitate initial positioning of the magnetometer. Depending on need for possible further positioning, the researcher may or may not leave the room after device positioning. The subject will be asked to remain still during data acquisition. (Should the subject become uncomfortable or simply need to move around, he or she will have complete freedom to do so and that particular measurement will be terminated.) Visual and audio contact with the subject will be maintained at all times via an open window in the magnetically shielded room. Using the atomic magnetometer, up to five-minute MCG recordings will be made at several locations in order to map the signal. The recordings will be analyzed off-line. An MCG or fMCG may also be recorded with Dr. Wakai's commercial Magnes and Tristan SQUID magnetometers, using similar acquisition parameters and processing procedures as for the AM. The purpose of the SQUID measurement is to compare the attained waveforms. Processing procedures for the SQUID data are identical to the atomic magnetometer data.
A typical recording session will consist of about 10 minutes for magnetometer alignment and optimization, followed by several 5-minute magnetometer acquisition periods separated by rest breaks during which the subject can relax and preliminary data analysis will be conducted by the researchers. The session may be completed by a SQUID measurement, requiring an additional 15 minutes, and by a brief exit interview to see if the subject had any comfort issues that were not identified during the session. The total recording session will take up to 2 hours .
- Conditions
- Fetal Heart Disorder
- Being tested
- Atomic Biomagnetometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomic BiomagnetometerDevice
Measure magnetic field of fetal heartbeat
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Measure magnetic field versus time for fetus, using atomic biomagnetometer. Receives: Device: Atomic Biomagnetometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Atomic Magnetometer
Measure single-to-noise for acquisition of fetal magnetocardiograms
Measured: 20-35 week gestation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startOct 2010
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thad Walker, PhD, Principal investigator, Univ. of Wisconsin-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057665
- Sponsor's protocol ID
- H-2008-0099
- Status last verified
- May 2019
- First submitted
- 15 Feb 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atomic Magnetometer for Fetal Biomagnetism
- ClinicalTrials.gov ID
- NCT03057665
- Acronym / sponsor ID
- H-2008-0099
- Conditions
- Fetal Heart Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Feb 2017 (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 goal of this study is the evaluation of an atomic magnetometer that is practical for human biomagnetism studies. The investigators have built a device that has the necessary sensitivity, and will be testing it on a small number of adults and approximately 30 healthy pregnant subjects, in preparation for beginning pre-clinical studies of high-risk pregnancies.
Detailed description
The goal of this study is evaluation of our atomic magnetometer for adult and fetal MCG studies. The investigators will assess the signal-to-noise and bandwidth performance under human acquisition conditions. They will also gain experience with the practical issues associated with making the measurements on human subjects.
The measurement sessions will take place in the magnetically shielded room in the UW Biomagnetism Laboratory, where similar studies have been made with SQUID detectors for more than 20 years, without incident. The room contains a bed and/or chair on which the subject may comfortably lie or sit.
The subject will remove all metal and magnetic objects (e.g. watches, glasses, jewelry, coins) and change into metal-free clothing. The subject will put on laser eye protection goggles. The subject will lie or sit on the patient bed in the magnetically shielded room with his or her chest (or stomach in the case of a pregnant mother) as close as possible to the magnetometer (typically 1 cm away), and will be monitored closely through a small opening in the shielded room to ensure comfort throughout the study. Positioning of the device with respect to the patient will be done by one of the researchers. In the case of pregnant women, an ultrasound will be taken to ascertain the position of the baby and facilitate initial positioning of the magnetometer. Depending on need for possible further positioning, the researcher may or may not leave the room after device positioning. The subject will be asked to remain still during data acquisition. (Should the subject become uncomfortable or simply need to move around, he or she will have complete freedom to do so and that particular measurement will be terminated.) Visual and audio contact with the subject will be maintained at all times via an open window in the magnetically shielded room. Using the atomic magnetometer, up to five-minute MCG recordings will be made at several locations in order to map the signal. The recordings will be analyzed off-line. An MCG or fMCG may also be recorded with Dr. Wakai's commercial Magnes and Tristan SQUID magnetometers, using similar acquisition parameters and processing procedures as for the AM. The purpose of the SQUID measurement is to compare the attained waveforms. Processing procedures for the SQUID data are identical to the atomic magnetometer data.
A typical recording session will consist of about 10 minutes for magnetometer alignment and optimization, followed by several 5-minute magnetometer acquisition periods separated by rest breaks during which the subject can relax and preliminary data analysis will be conducted by the researchers. The session may be completed by a SQUID measurement, requiring an additional 15 minutes, and by a brief exit interview to see if the subject had any comfort issues that were not identified during the session. The total recording session will take up to 2 hours .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Device: Atomic BiomagnetometerMeasure magnetic field versus time for fetus, using atomic biomagnetometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 35 normal, nominally healthy adult volunteers (18 years or older) will be studied, including 30 pregnant women. The pregnant women will be healthy women with uncomplicated pregnancies. They will be studied at gestational ages 18-38 weeks, with studies terminating at 38 weeks or before. The non-pregnant adults will be either the PIs or other volunteers who do not have status relationship to the study investigators.
Key inclusion criteria (1 listed)
- The subjects will be asked if they consider themselves healthy, if they are able to sit or lie still for 5 minute periods during data acquisition, if they have large metal plates, screws, or devices, and if they are pregnant.
Key exclusion criteria (1 listed)
- Participants who self-identify as being unhealthy or having complications with their pregnancy. In addition, vulnerable populations such as prisoners, veterans, individuals with impaired decision-making capabilities, and non-English speakers will be excluded.
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 |
|---|---|---|
| Atomic BiomagnetometerMeasure magnetic field of fetal heartbeat | Device | Pregnant Women |
Primary outcome
Assessment of Atomic Magnetometer
Time frame: 20-35 week gestation period
Measure single-to-noise for acquisition of fetal magnetocardiograms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- 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.
Thad Walker, PhD principal investigator
Univ. of Wisconsin-Madison
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 Heart Disorder, run by University of Wisconsin, Madison 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 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: finished, as of the sponsor's last update on 24 May 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of Atomic Magnetometer (time frame: 20-35 week gestation period). 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 24 May 2019.