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.
Study Type
OBSERVATIONAL
Enrollment
38
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 patch will be placed on subject abdomen for 18 hours (+/- 2 hours) of wear. Evaluation of skin integrity and patch performance will be assessed.
GE HealthCare Research Park
Wauwatosa, Wisconsin, United States
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.
Time frame: 18 hours
Collection of ECG Electrical Signal Data
Collection of electrocardiogram (ECG) electrical signal data from the patch after 18 hours of wear.
Time frame: 18 hours
Collection of Subject Activity
Collect of subject activity data utilizing a subject questionnaire during the 18 hours of wear.
Time frame: 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
Time frame: 18 Hours
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