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Completed

NCT Number: NCT02496429

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Dr. Geißenhofer, Munich, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BrownieForSymphony use

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Registry information

Official study title

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

Acronym: ESP

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2015
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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