Lactation
Conditions
Brief summary
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.
Interventions
PROCEDUREFluid filled breast pump
breast milk pumping with a fluid filled breast pump
Sponsors
Medela AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female over 18 years * Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session * The participant is pumping at least 2 times a week * The participant is 1-6 months after giving birth (postpartum) at the day of data assessment * The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions * The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed) * The participant agrees to photograph and video record the breast and upper body (no face) * The participant agrees to the presence of up to 3 men in the room during the pumping session
Exclusion criteria
* Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.) * Participant has an medical condition of the breast * Participant is allergic to plastics or silicone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast pump vacuum (mmHg) | Measured during a single 25 minute pumping session | Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes. |
Countries
Switzerland
Outcome results
None listed