Status:
COMPLETED
Engineering Evaluation of a Breast Pump Device
Lead Sponsor:
Momtech Inc.
Conditions:
Healthy
Breast Pumping
Eligibility:
FEMALE
18+ years
Phase:
NA
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 h...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05222581
Start Date
January 19 2022
End Date
September 30 2024
Last Update
May 9 2025
Active Locations (1)
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1
Blur Product Development
Cary, North Carolina, United States, 27513