Evaluation of the Goldcrest Patch Performance

NCT06355453 | Completed FDA Device

• 1 other identifier: 2023-090-MIC-GES
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Monitoring

Keywords

Fetal Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Collection of ECG Electrical Signal Data

  18 hours

• Collection of Subject Activity

  18 hours

• Collection of Patch Electrical Signal Data

  18 Hours

Other Outcomes (1)

• Safety Analysis

  4 months

Study Arms (2)

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

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

Interventions

Goldcrest Patch and Three Patch Coupons DEVICE

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.

Pregnant Woman Arm

Goldcrest Patch and Novii Patch DEVICE

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.

Non-Pregnant Woman Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample in Milwaukee, Wisconsin area.

You may qualify if:

• Adult Females, 22 to 70 years of age.
• Must be able to read and speak English.
• Able and willing to provide written informed consent.
• \- Pregnancy of greater than or equal to 32.0 weeks gestation per self-report.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE HealthCare Research Park

Wauwatosa, Wisconsin, 53188, United States

Location

Related Publications (2)

• 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.

  PMID: 19370591 BACKGROUND

• 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.

  PMID: 24022422 BACKGROUND

Related Links

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

Study Officials

• Linda Systems Engineering Manager

  GE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 9, 2024
• Study Start: April 22, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)