Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use (ESPII)

Medela

Status

Completed

Conditions

Lactation

Treatments

Device: Pumping CE-marked Symphony Pumpset

Device: Pumping BrownieForSymphony Pumpset

Study type

Interventional

Funder types

Industry

Identifiers

NCT02492139

MBF1503

Details and patient eligibility

About

The overall purpose of this study is to evaluate the reliability and usability of the reusable BrownieForSymphony pump set in home use.

The primary objectives of this study is to asses and compare the System Usability Scale (SUS) score of the BrownieForSymphony pump set and the current used Symphony pump set.

Secondary Objectives

The secondary objectives of this study are:

to evaluate the rate of usability problems with the BrownieForSymphony pump set

to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set
to evaluate perceived comfort during pumping with the BrownieForSymphony pump set Prospective Cohort Study (quasi Cross over design)

Enrollment

22 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Lactating woman >18 years who
- Have been pumping for at least 7 days with the Symphony pump and pump set prior to study participation
- Have been pumping at least 10 times in the week prior to study participation
- Consistently pump 10 ml of milk or more per breast, per pumping session prior to study participation
- Currently use a breast shield size of 24 mm
- Participant has agreed to pump at least 10 times a week over the next three weeks

Exclusion criteria