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

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

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)

Study Overview

• Status: Completed
• Conditions: Lactation
• Intervention / Treatment: Device: Pumping CE-marked Symphony Pumpset; Device: Pumping BrownieForSymphony Pumpset

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zug
    • Baar, Zug, Switzerland, 6341
      • Medela AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pumping; Each particpant will pump with the current pumpset one week and then two weeks with the pumpset	Device: Pumping CE-marked Symphony Pumpset; Pumping with the CE-marked Symphony Pumpset; Device: Pumping BrownieForSymphony Pumpset; Pumping with the the BrownieForSymphony Pumpset

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medela AG
• Investigators: Principal Investigator: Nicole Steinfelder, Medela AG

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MBF1503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No