Engineering Evaluation of a Breast Pump Device

NCT ID: NCT05222581

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Breast Pumping

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Prototypes of Breast Shield and Freedom Double Electric Breast Pump

Prototypes of breast shield and Freedom Double Electric Breast Pump

Group Type EXPERIMENTAL

Prototypes of breast shield and Freedom Double Electric Breast Pump

Intervention Type DEVICE

Prototypes of breast shield and Freedom Double Electric Breast Pump.

Interventions

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Prototypes of breast shield and Freedom Double Electric Breast Pump

Prototypes of breast shield and Freedom Double Electric Breast Pump.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Momtech Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Wofford Leong, MD

Role: PRINCIPAL_INVESTIGATOR

Independent Physician

Locations

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Blur Product Development

Cary, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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MOMI-001

Identifier Type: -

Identifier Source: org_study_id

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