Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02492139
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Lactation Device: Pumping CE-marked Symphony Pumpset Device: Pumping BrownieForSymphony Pumpset Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Usability Scale (SUS) Symphony Pumpset usability [ Time Frame: after 7 days ]
    Rating of the Usability of the Symphony Pumpset

  2. Usability Scale (SUS) BrownieForSymphony Pumpset usability [ Time Frame: after 14 days ]
    Rating of the Usability of the Symphony Pumpset


Secondary Outcome Measures :
  1. User experience questionnaire (UEQ) [ Time Frame: after 7 days, 14 days, 3 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492139


Locations
Layout table for location information
Switzerland
Medela AG
Baar, Zug, Switzerland, 6341
Sponsors and Collaborators
Medela AG
Investigators
Layout table for investigator information
Principal Investigator: Nicole Steinfelder Medela AG

Layout table for additonal information
Responsible Party: Medela AG
ClinicalTrials.gov Identifier: NCT02492139     History of Changes
Other Study ID Numbers: MBF1503
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016