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

Lactation Clinical Trial

— ESPII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492139
• Other study ID #: MBF1503
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2020
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lactation

Intervention

Device:
• Pumping CE-marked Symphony Pumpset
Pumping with the CE-marked Symphony Pumpset
• Pumping BrownieForSymphony Pumpset
Pumping with the the BrownieForSymphony Pumpset

Locations

Country	Name	City	State
Switzerland	Medela AG	Baar	Zug

Sponsors (1)

Lead Sponsor	Collaborator
Medela AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability Scale (SUS) Symphony Pumpset usability	Rating of the Usability of the Symphony Pumpset	after 7 days
Primary	Usability Scale (SUS) BrownieForSymphony Pumpset usability	Rating of the Usability of the Symphony Pumpset	after 14 days
Secondary	User experience questionnaire (UEQ)		after 7 days, 14 days, 3 week