Engineering Evaluation of a Breast Pump Device

Last updated: May 6, 2025
Sponsor: Momtech Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Prototypes of breast shield and Freedom Double Electric Breast Pump

Clinical Study ID

NCT05222581
MOMI-001
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of good health

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

  • 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

Exclusion Criteria:

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

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

  • Not currently pregnant

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Prototypes of breast shield and Freedom Double Electric Breast Pump
Phase:
Study Start date:
January 19, 2022
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Blur Product Development

    Cary, North Carolina 27513
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.