Engineering Evaluation of a Breast Pump Device

NCT05222581 | Completed FDA Device

• 1 other identifier: MOMI-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 health outcomes.

Conditions

Healthy; Breast Pumping

Outcome Measures

Primary Outcomes (3)

• Breast shield comfort

  Rate comfort of device by Questionnaire

  1 day (Single timepoint)

• Breast shield fit

  Rate fit of device by Questionnaire

  1 day (Single timepoint)

• Breast shield ease of use

  Rate ease of use of device by Questionnaire

  1 day (Single timepoint)

Secondary Outcomes (3)

• Volume of milk expressed

  1 day (Single Timepoint)

• Participant comparison of device to current commercial breast pump

  1 day (single timepoint)

• Participant comparison of device to breastfeeding

  1 day (single visit)

Study Arms (1)

Prototypes of Breast Shield and Freedom Double Electric Breast Pump

EXPERIMENTAL

Prototypes of breast shield and Freedom Double Electric Breast Pump

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Momtech Inc.: lead

Study Sites (1)

Blur Product Development

Cary, North Carolina, 27513, United States

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Ashley Wofford Leong, MD

  Independent Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prototype breast shield designs for the Freedom Double Electric Breast Pump with \<10 subjects per breast shield design. The study sample size is appropriate for a small feasibility study evaluating design concepts because there are several breast shield designs being evaluated with a small number of subjects per design.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 3, 2022
• Study Start: January 19, 2022
• Primary Completion: June 1, 2024
• Study Completion: September 30, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)