Engineering Evaluation of a Breast Pump Device

Momtech Inc.

Status

Completed

Conditions

Healthy

Breast Pumping

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05222581

MOMI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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