Fetal MonitoringNCT06355453
Evaluation of the Goldcrest Patch Performance
An observational study of Fetal Monitoring, run by GE Healthcare at 1 site in United States.
Trial summary
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen. The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- Goldcrest Patch and Three Patch Coupons and Goldcrest Patch and Novii Patch
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 31 Mar 2025
- 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 22 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample in Milwaukee, Wisconsin area.
Who may be able to join
- Adult Females, 22 to 70 years of age.
- Must be able to read and speak English.
- Able and willing to provide written informed consent.
- Inclusion criteria that apply to the pregnant person arm only:
- Pregnancy of greater than or equal to 32.0 weeks gestation per self-report.
Who cannot join
- Skin irregularities or other characteristic (such as scars, moles) on abdominal area that could interfere with completion of study procedures or identify a subject;
- Subjects who have implantable devices such as Transcutaneous Electrical Nerve Stimulation (TENS) machines, Cardiac Pacemakers or Cardiac Defibrillators
- Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study, such as silicone;
- Subjects over the age of 70;
- Unable to read or speak English language
- Direct employees or contractors of GE HealthCare, or any company that makes fetal monitoring devices.
- Non-Pregnant Arm: Subjects who are currently pregnant, or unsure of pregnancy status per self-report;
- Pregnant Arm: Multiple gestation pregnancy or those self-reported to have been diagnosed as high risk by a provider (e.g., pre-eclampsia, gestational hypertension, being followed by a perinatologist).
Trial locations and contacts
1 site in 1 country.
United States1 site
GE HealthCare Research Park
Wauwatosa, Wisconsin, 53188
About this study
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
Read the detailed description
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
- Conditions
- Fetal Monitoring
- Being tested
- Goldcrest Patch and Three Patch Coupons, Goldcrest Patch and Novii Patch
- Keywords
- Fetal Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goldcrest Patch and Three Patch CouponsDevice
Goldcrest patch and three patch coupons will be placed on subject abdomen for 18 hours (+/- 2 hours) of wear. Evaluation of skin integrity and patch performance will be assessed.
Goldcrest Patch and Novii PatchDevice
Goldcrest patch and Novii patch will be placed on subject abdomen for 18 hours (+/- 2 hours) of wear. Evaluation of skin integrity and patch performance will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Woman Arm | Subjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen. Receives: Device: Goldcrest Patch and Three Patch Coupons | |
| Non-Pregnant Woman Arm | Subjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen. Receives: Device: Goldcrest Patch and Novii Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Skin Integrity Quality
To collect of skin integrity quality from a skin assessment scale the from the patch's after 18-hours of wear.
Measured: 18 hours
Secondary outcomes (3)
Collection of ECG Electrical Signal Data
Collection of electrocardiogram (ECG) electrical signal data from the patch after 18 hours of wear.
Measured: 18 hours
Collection of Subject Activity
Collect of subject activity data utilizing a subject questionnaire during the 18 hours of wear.
Measured: 18 hours
Collection of Patch Electrical Signal Data
Collection of electrical signal data from the patch's at the time of application for comparison to the electrical data after 18 hours of wear
Measured: 18 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 Apr 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Systems Engineering Manager, Principal investigator, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355453
- Sponsor's protocol ID
- 2023-090-MIC-GES
- Status last verified
- Jun 2025
- First submitted
- 11 Mar 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is an early phase investigation of a device
Publications
Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003934. doi: 10.1002/14651858.CD003934.pub2.
PubMed 19370591McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. Orthop Nurs. 2013 Sep-Oct;32(5):267-81. doi: 10.1097/NOR.0b013e3182a39caf.
PubMed 24022422
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Goldcrest Patch Performance
- ClinicalTrials.gov ID
- NCT06355453
- Acronym / sponsor ID
- 2023-090-MIC-GES
- Conditions
- Fetal Monitoring
- Keywords
- Fetal Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 9 Apr 2024 (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 Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
Detailed description
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Woman Arm | – | Device: Goldcrest Patch and Three Patch CouponsSubjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen. |
| Non-Pregnant Woman Arm | – | Device: Goldcrest Patch and Novii PatchSubjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample in Milwaukee, Wisconsin area.
Key inclusion criteria (5 listed)
- Adult Females, 22 to 70 years of age.
- Must be able to read and speak English.
- Able and willing to provide written informed consent.
- Pregnancy of greater than or equal to 32.0 weeks gestation per self-report.
Key exclusion criteria (8 listed)
- Skin irregularities or other characteristic (such as scars, moles) on abdominal area that could interfere with completion of study procedures or identify a subject;
- Subjects who have implantable devices such as Transcutaneous Electrical Nerve Stimulation (TENS) machines, Cardiac Pacemakers or Cardiac Defibrillators
- Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study, such as silicone;
- Subjects over the age of 70;
- Unable to read or speak English language
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 |
|---|---|---|
| Goldcrest Patch and Three Patch CouponsGoldcrest patch and three patch coupons will be placed on subject abdomen for 18 hours (+/- 2 hours) of wear. Evaluation of skin integrity and patch performance will be assessed. | Device | Pregnant Woman Arm |
| Goldcrest Patch and Novii PatchGoldcrest patch and Novii patch will be placed on subject abdomen for 18 hours (+/- 2 hours) of wear. Evaluation of skin integrity and patch performance will be assessed. | Device | Non-Pregnant Woman Arm |
Primary outcome
Collection of Skin Integrity Quality
Time frame: 18 hours
To collect of skin integrity quality from a skin assessment scale the from the patch's after 18-hours of wear.
3 secondary outcomes
Collection of ECG Electrical Signal Data
Time frame: 18 hours
Collection of Subject Activity
Time frame: 18 hours
Collection of Patch Electrical Signal Data
Time frame: 18 Hours
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 14 Jul 2025.
- Background: PubMed 19370591Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003934. doi: 10.1002/14651858.CD003934.pub2.
- Background: PubMed 24022422McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. Orthop Nurs. 2013 Sep-Oct;32(5):267-81. doi: 10.1097/NOR.0b013e3182a39caf.
- American National Standard Disposable ECG electrodes, ANSI/AAMI EC12:2000/(R)2020Link provided by the sponsor.
- Individual participant dataSharing planned: No. This is an early phase investigation of a device
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Induced Labor, Cervical Ripening
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Fetal Hypoxia, Fetal Distress
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Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
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Recruiting
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
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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.
Linda Systems Engineering Manager principal investigator
GE Healthcare
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 Monitoring, run by GE Healthcare 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 8 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 14 Jul 2025. 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?
Collection of Skin Integrity Quality (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355453, which also lists 2 linked publications.
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 14 Jul 2025.