Evaluation of the Functionality of a Fluid Filled Single Breast Pump (C88)

Medela

Status: Completed

Conditions: Lactation

Treatments: Procedure: Fluid filled breast pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542527

MBF1504

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Pumping with a fluid filled breast pump

Experimental group

Description:

Participants pump (each breast 25 min) with the new fluid filled breast pump

Treatment:

Procedure: Fluid filled breast pump