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

February 7, 2020 updated by: Medela AG

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medela AG

Investigators

  • Principal Investigator: Nicole Steinfelder, Medela AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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