Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set in Home Use

ESP II Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set in Home Use

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02492139

Acronym

ESPII

Enrollment

Registered

2015-07-08

Start date

2015-07-31

Completion date

2015-11-30

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation

Brief summary

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)

Interventions

DEVICEPumping CE-marked Symphony Pumpset

Pumping with the CE-marked Symphony Pumpset

DEVICEPumping BrownieForSymphony Pumpset

Pumping with the the BrownieForSymphony Pumpset

Study design

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

* o Woman has a medical condition of the breast (eg. Mastitis)

Design outcomes

Primary

Measure	Time frame	Description
Usability Scale (SUS) Symphony Pumpset usability	after 7 days	Rating of the Usability of the Symphony Pumpset
Usability Scale (SUS) BrownieForSymphony Pumpset usability	after 14 days	Rating of the Usability of the Symphony Pumpset

Secondary

Measure	Time frame
User experience questionnaire (UEQ)	after 7 days, 14 days, 3 week

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026