NCT06355453

Evaluation of the Goldcrest Patch Performance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fetal Monitoring

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-04-09
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study