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NCT02496429 Clinical Trial

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

Lactation Clinical Trial

— ESP  

Official title:
ESP Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02496429
Other study ID # MBF1502
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date September 2015

Study information
Verified date February 2020
Source Medela AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Klinik Dr. Geißenhofer Munich
Germany University Tuebingen Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
Medela AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Usability Scale (SUS) Symphony Pumpset usability Rating of the Usability of the Symphony Pumpset day at inclusion
Primary Usability Scale (SUS) BrownieForSymphony Pumpset usability Rating of the Usability of the BrownieForSymphony Pumpset after 5 days
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