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Evaluation of the Goldcrest Patch Performance

NCT06355453 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Linda Systems Engineering Manager · GE Healthcare

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355453 on ClinicalTrials.gov