Engineering Evaluation of a Breast Pump Device

Healthy Clinical Trial

Official title:

Engineering Evaluation of a Breast Pump Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05222581
• Other study ID #: MOMI-001
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Momtech Inc.
• Contact: Research Coordinator
• Phone: 919-257-1769
• Email: ccoleman[@]blurpd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.

Description:

This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of good health

• Currently lactating and planning to continue breastfeeding for the next 3 to 4 months

• Currently using a commercial electric breast pump at least several times a week

• Sufficient milk supply for one missed infant feeding per device testing visit

• Willing to attend five device testing visits over 3 to 4 months

• Willing to be video recorded during device testing

• Willing to discard milk collected during testing

Exclusion Criteria:

• No active breast or nipple injury, breast inflammation or infection, or nipple piercing

• No prior history of breast implant, reduction or reconstruction surgery

• Not currently pregnant

Related Conditions & MeSH terms

• Breast Pumping
• Healthy

Intervention

Device:
• Prototypes of breast shield and Freedom Double Electric Breast Pump
Prototypes of breast shield and Freedom Double Electric Breast Pump.

Locations

Country	Name	City	State
United States	Blur Product Development	Cary	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Momtech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast shield comfort	Rate comfort of device by Questionnaire	1 day (Single timepoint)
Primary	Breast shield fit	Rate fit of device by Questionnaire	1 day (Single timepoint)
Primary	Breast shield ease of use	Rate ease of use of device by Questionnaire	1 day (Single timepoint)
Secondary	Volume of milk expressed	Rate volume of milk expressed with device by Questionnaire	1 day (Single Timepoint)
Secondary	Participant comparison of device to current commercial breast pump	Rate comparison of device to current breast pump experience by Questionnaire	1 day (single timepoint)
Secondary	Participant comparison of device to breastfeeding	Rate comparison of device to breastfeeding experience by Questionnaire	1 day (single visit)