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CompletedNCT02496429ESPUpdated Feb 10, 2020

Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set

An interventional study of BrownieForSymphony use in Lactation, sponsored by Medela AG. Completed at 2 sites in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Medela AG · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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
Read the detailed description

This is a 5 day case study to evaluate the reliability and usability of the BrownieForSymphony pump set.

The study consists of two different participant groups, professionals (e.g. lactation consultants, nurses) and lactating women.

02

Conditions studied

  • Lactation
03

In context

Lead sponsor

Medela AG is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    BrownieForSymphony use

    Each participant will use the BrownieForSymphony pumpset

    Device: BrownieForSymphony use

Interventions

  • DeviceBrownieForSymphony use

    Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset

06

What researchers measure

Primary outcomes

  1. Usability Scale (SUS) Symphony Pumpset usability

    Rating of the Usability of the Symphony Pumpset

    Time frame: day at inclusion

  2. Usability Scale (SUS) BrownieForSymphony Pumpset usability

    Rating of the Usability of the BrownieForSymphony Pumpset

    Time frame: after 5 days

07

Study locations

2 sites
  • Klinik Dr. Geißenhofer
    Munich, 80538, Germany
  • University Tuebingen
    Tuebingen, 72076, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02496429
Lead sponsor
Medela AG
Responsible party
Sponsor
First posted
Jul 14, 2015
Start date
Jul 2015
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Feb 10, 2020

Study contacts

Danielle Prime, PhD
principal investigator · Medela AG

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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