Fetal Monitoring
Conditions
Keywords
Fetal Monitoring
Brief 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. 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.
Interventions
DEVICEGoldcrest Patch and Three Patch Coupons
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.
DEVICEGoldcrest Patch and Novii Patch
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.
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for all Subjects: * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Skin Integrity Quality | 18 hours | To collect of skin integrity quality from a skin assessment scale the from the patch's after 18-hours of wear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of ECG Electrical Signal Data | 18 hours | Collection of electrocardiogram (ECG) electrical signal data from the patch after 18 hours of wear. |
| Collection of Subject Activity | 18 hours | Collect of subject activity data utilizing a subject questionnaire during the 18 hours of wear. |
| Collection of Patch Electrical Signal Data | 18 Hours | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Analysis | 4 months | 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. |
Countries
United States
Outcome results
None listed