Evaluation of the Goldcrest Patch Performance

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.

Study Overview

• Status: Completed
• Conditions: Fetal Monitoring
• Intervention / Treatment: Device: Goldcrest Patch and Three Patch Coupons; Device: Goldcrest Patch and Novii Patch

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53188
      • GE HealthCare Research Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Community sample in Milwaukee, Wisconsin area.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Woman Arm; Subjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen.	Device: Goldcrest 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.
Non-Pregnant Woman Arm; Subjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen.	Device: Goldcrest 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Linda Systems Engineering Manager, GE Healthcare

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• American National Standard Disposable ECG electrodes, ANSI/AAMI EC12:2000/(R)2020

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Fetal Monitoring
• Other Study ID Numbers: 2023-090-MIC-GES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an early phase investigation of a device

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No