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OpenTrials
Completed

NCT Number: NCT05222581

Engineering Evaluation of a Breast Pump Device

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.

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Key information

Conditions

Healthy Behavior Breast Feeding Breast Milk Expression Breast Pumping Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Blur Product Development

Cary, North Carolina, 27513, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prototypes of breast shield and Freedom Double Electric Breast Pump

Device

Prototypes of breast shield and Freedom Double Electric Breast Pump.

Primary outcomes

  1. Breast shield comfort

    Time frame: 1 day (Single timepoint)

    Rate comfort of device by Questionnaire

  2. Breast shield fit

    Time frame: 1 day (Single timepoint)

    Rate fit of device by Questionnaire

  3. Breast shield ease of use

    Time frame: 1 day (Single timepoint)

    Rate ease of use of device by Questionnaire

Secondary outcomes

  1. Volume of milk expressed

    Time frame: 1 day (Single Timepoint)

    Rate volume of milk expressed with device by Questionnaire

  2. Participant comparison of device to current commercial breast pump

    Time frame: 1 day (single timepoint)

    Rate comparison of device to current breast pump experience by Questionnaire

  3. Participant comparison of device to breastfeeding

    Time frame: 1 day (single visit)

    Rate comparison of device to breastfeeding experience by Questionnaire

Sponsors and collaborators

Lead sponsor

Momtech Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2022
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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