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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Woman Arm | Subjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen. |
| |
| Non-Pregnant Woman Arm | Subjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goldcrest Patch and Three Patch Coupons | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of ECG Electrical Signal Data | Collection of electrocardiogram (ECG) electrical signal data from the patch after 18 hours of wear. | 18 hours |
| Collection of Subject Activity | Collect of subject activity data utilizing a subject questionnaire during the 18 hours of wear. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis | Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events. | 4 months |
Inclusion Criteria for all Subjects:
Inclusion criteria that apply to the pregnant person arm only:
- Pregnancy of greater than or equal to 32.0 weeks gestation per self-report.
Exclusion Criteria:
Exclusion criteria that apply to specific arms only:
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Community sample in Milwaukee, Wisconsin area.
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| Name | Affiliation | Role |
|---|---|---|
| Linda Systems Engineering Manager | GE Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE HealthCare Research Park | Wauwatosa | Wisconsin | 53188 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19370591 | Background | 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. | |
| 24022422 | Background | McNichol 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. |
| Label | URL |
|---|---|
| American National Standard Disposable ECG electrodes, ANSI/AAMI EC12:2000/(R)2020 | View source |
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This is an early phase investigation of a device
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| Goldcrest Patch and Novii Patch | Device | 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. |
|
| 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 | 18 Hours |