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Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set (ESP)

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ClinicalTrials.gov Identifier: NCT02496429
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Medela AG

Brief Summary:

The primary objectives of this study is to evaluate how professionals rate the reliability and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump set

4.2 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 first impression of lactating woman regarding pumping with the BrownieForSymphony pump set

Condition or disease Intervention/treatment Phase
Lactation Device: BrownieForSymphony use Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ESP Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
BrownieForSymphony use
Each participant will use the BrownieForSymphony pumpset
Device: BrownieForSymphony use
Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset




Primary Outcome Measures :
  1. Usability Scale (SUS) Symphony Pumpset usability [ Time Frame: day at inclusion ]
    Rating of the Usability of the Symphony Pumpset

  2. Usability Scale (SUS) BrownieForSymphony Pumpset usability [ Time Frame: after 5 days ]
    Rating of the Usability of the BrownieForSymphony Pumpset



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Hospitalized lactating woman >18 years which are pumping breast milk

Exclusion Criteria:

  • hospitalized lactating woman has a medical indication for pumping (e.g. Mastitis, cracked nipples) lactating woman used a breast shield size >27 and <24

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): NCT02496429


Locations
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Germany
Klinik Dr. Geißenhofer
Munich, Germany, 80538
University Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
Medela AG
Investigators
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Principal Investigator: Danielle Prime, PhD Medela AG

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Responsible Party: Medela AG
ClinicalTrials.gov Identifier: NCT02496429     History of Changes
Other Study ID Numbers: MBF1502
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015