Evaluation of the Goldcrest Patch Performance

Active, not recruiting

• Conditions: Fetal Monitoring
• Interventions: Device: Goldcrest Patch and Three Patch Coupons; Device: Goldcrest Patch and Novii Patch

• Registration Number: NCT06355453
• Lead Sponsor: GE Healthcare

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.

Study Timeline

• Study First Submitted: 2024-03-11
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-09
• Study Start: 2024-04-22
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Woman Arm	Goldcrest Patch and Three Patch Coupons	Subjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen.
Non-Pregnant Woman Arm	Goldcrest Patch and Novii Patch	Subjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GE HealthCare Research Park; 🇺🇸 Wauwatosa, Wisconsin, United States