Engineering Evaluation of a Breast Pump Device

Study Overview
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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.

Official Title
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Engineering Evaluation of a Breast Pump Device

Conditions
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Healthy, Breast Pumping

Intervention / Treatment
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* Device: Prototypes of breast shield and Freedom Double Electric Breast Pump


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Prototype breast shield designs for the Freedom Double Electric Breast Pump with <10 subjects per breast shield design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototypes of Breast Shield and Freedom Double Electric Breast Pump<br>Prototypes of breast shield and Freedom Double Electric Breast Pump | Device: Prototypes of breast shield and Freedom Double Electric Breast Pump<br>* Prototypes of breast shield and Freedom Double Electric Breast Pump.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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