Evaluation of the Goldcrest Patch Performance

Fetal Monitoring Clinical Trial

Official title:

Evaluation of the Goldcrest Patch Performance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355453
• Other study ID #: 2023-090-MIC-GES
• Status: Not yet recruiting
• Start date: April 25, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: GE Healthcare
• Contact: Amie Research Program Integrator
• Phone: 816-719-6567
• Email: Amie.Robnison[@]geHealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fetal Monitoring

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events Objective	The safety objective of this study is to collect safety information, including type and number of AEs, SAEs, and device issues.	4 months
Primary	Primary Objective	The primary objective of this study is to collect data on skin integrity quality utilizing a skin assessment scale the from the patch after 18-hours of wear.	18 hours
Primary	Primary Objective	The primary objective of this study is to collect data on adhesion and residue utilizing an adhesion and residue assessment scale from the patch after 18-hours of wear.	18 hours
Secondary	Secondary Objective	To collect electrocardiogram (ECG) electrical signal data from the patch after 18 hours of wear.	18 hours
Secondary	Secondary Objective	To collect subject activity data utilizing a subject questionnaire during the 18 hours of wear.	18 hours

External Links

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