Engineering Evaluation of a Breast Pump Device

Not Applicable

Completed

• Conditions: Breast Pumping; Healthy
• Interventions: Device: Prototypes of breast shield and Freedom Double Electric Breast Pump

• Registration Number: NCT05222581
• Lead Sponsor: Momtech Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-11
• Study Start: 2022-01-19
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prototypes of Breast Shield and Freedom Double Electric Breast Pump	Prototypes of breast shield and Freedom Double Electric Breast Pump	Prototypes of breast shield and Freedom Double Electric Breast Pump

Primary Outcome Measures

Name	Time	Method
Breast shield fit	1 day (Single timepoint)	Rate fit of device by Questionnaire
Breast shield comfort	1 day (Single timepoint)	Rate comfort of device by Questionnaire
Breast shield ease of use	1 day (Single timepoint)	Rate ease of use of device by Questionnaire

Secondary Outcome Measures

Name	Time	Method
Participant comparison of device to breastfeeding	1 day (single visit)	Rate comparison of device to breastfeeding experience by Questionnaire
Participant comparison of device to current commercial breast pump	1 day (single timepoint)	Rate comparison of device to current breast pump experience by Questionnaire
Volume of milk expressed	1 day (Single Timepoint)	Rate volume of milk expressed with device by Questionnaire

Trial Locations

Locations (1)

Blur Product Development; 🇺🇸 Cary, North Carolina, United States