Engineering Evaluation of a Breast Pump Device

May 6, 2025 updated by: Momtech Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • Blur Product Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prototypes of Breast Shield and Freedom Double Electric Breast Pump
Prototypes of breast shield and Freedom Double Electric Breast Pump
Device: Prototypes of breast shield and Freedom Double Electric Breast Pump
Prototypes of breast shield and Freedom Double Electric Breast Pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast shield comfort
Time Frame: 1 day (Single timepoint)
Rate comfort of device by Questionnaire
1 day (Single timepoint)
Breast shield fit
Time Frame: 1 day (Single timepoint)
Rate fit of device by Questionnaire
1 day (Single timepoint)
Breast shield ease of use
Time Frame: 1 day (Single timepoint)
Rate ease of use of device by Questionnaire
1 day (Single timepoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of milk expressed
Time Frame: 1 day (Single Timepoint)
Rate volume of milk expressed with device by Questionnaire
1 day (Single Timepoint)
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
1 day (single timepoint)
Participant comparison of device to breastfeeding
Time Frame: 1 day (single visit)
Rate comparison of device to breastfeeding experience by Questionnaire
1 day (single visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Momtech Inc.

Investigators

  • Principal Investigator: Ashley Wofford Leong, MD, Independent Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MOMI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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