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Completed

NCT Number: NCT02492139

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

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)

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Key information

Conditions

Lactation Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medela AG

Baar, Canton of Zug, 6341, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Pumping CE-marked Symphony Pumpset

Device

Pumping with the CE-marked Symphony Pumpset

Pumping BrownieForSymphony Pumpset

Device

Pumping with the the BrownieForSymphony Pumpset

Primary outcomes

  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 outcomes

  1. User experience questionnaire (UEQ)

    Time frame: after 7 days, 14 days, 3 week

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Registry information

Official study title

ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use

Acronym: ESPII

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 8, 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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