Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototypes of Breast Shield and Freedom Double Electric Breast Pump | Experimental | Prototypes of breast shield and Freedom Double Electric Breast Pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototypes of breast shield and Freedom Double Electric Breast Pump | Device | Prototypes of breast shield and Freedom Double Electric Breast Pump. |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashley Wofford Leong, MD | Independent Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blur Product Development | Cary | North Carolina | 27513 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 1 day (single timepoint) |
| Participant comparison of device to breastfeeding | Rate comparison of device to breastfeeding experience by Questionnaire | 1 day (single visit) |