Clinical trial NCT06355453: Evaluation of the Goldcrest Patch Performance
Official title: Evaluation of the Goldcrest Patch Performance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fetal Monitoring
Keywords: Fetal Monitoring
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample in Milwaukee, Wisconsin area.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Collection of Skin Integrity Quality
timeFrame: 18 hours
Secondary outcomes:
measure: Collection of ECG Electrical Signal Data
timeFrame: 18 hours
measure: Collection of Subject Activity
timeFrame: 18 hours
measure: Collection of Patch Electrical Signal Data
timeFrame: 18 Hours
Other outcomes:
measure: Safety Analysis
timeFrame: 4 months
Locations:
city: Wauwatosa
country: United States
facility: GE HealthCare Research Park
state: Wisconsin
Study officials:
affiliation: GE Healthcare
name: Linda Systems Engineering Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.