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

NCT02492139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-02-10

No results posted yet for this study

Summary

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)

Conditions

  • Lactation

Interventions

DEVICE

Pumping CE-marked Symphony Pumpset

Pumping with the CE-marked Symphony Pumpset

DEVICE

Pumping BrownieForSymphony Pumpset

Pumping with the the BrownieForSymphony Pumpset

Sponsors & Collaborators

  • Medela AG

    lead INDUSTRY

Principal Investigators

  • Nicole Steinfelder · Medela AG

Study Design

Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02492139 on ClinicalTrials.gov