Evaluation of the Goldcrest Patch Performance

General Electric (GE)

Status

Active, not recruiting

Conditions

Fetal Monitoring

Treatments

Device: Goldcrest Patch and Novii Patch

Device: Goldcrest Patch and Three Patch Coupons

Study type

Observational

Funder types

Industry

Identifiers

NCT06355453

2023-090-MIC-GES

Details and patient eligibility

About

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.

Full description

Enrollment

30 estimated patients

Sex

Female

Ages

22 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion criteria that apply to specific arms only:

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).