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

Not Applicable

Completed

• Conditions: Lactation
• Interventions: Device: Pumping CE-marked Symphony Pumpset; Device: Pumping BrownieForSymphony Pumpset

• Registration Number: NCT02492139
• Lead Sponsor: Medela AG

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pumping	Pumping BrownieForSymphony Pumpset	Each particpant will pump with the current pumpset one week and then two weeks with the pumpset
Pumping	Pumping CE-marked Symphony Pumpset	Each particpant will pump with the current pumpset one week and then two weeks with the pumpset

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
User experience questionnaire (UEQ)	after 7 days, 14 days, 3 week

Trial Locations

Locations (1)

Medela AG; 🇨🇭 Baar, Zug, Switzerland