Evaluation of the Goldcrest Patch Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-22

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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

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Fetal Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Woman Arm

Subjects will have Goldcrest patch and three Novii electrodes will be placed on the subjects abdomen.

Goldcrest Patch and Three Patch Coupons

Intervention Type 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.

Non-Pregnant Woman Arm

Subjects will have Goldcrest patch and Novii Patch and electrodes will be placed on the subjects abdomen.

Goldcrest Patch and Novii Patch

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

* 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).

Minimum Eligible Age

22 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes