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

February 7, 2020 updated by: Medela AG

ESP 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BrownieForSymphony use
Each participant will use the BrownieForSymphony pumpset
Device: BrownieForSymphony use
Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Scale (SUS) Symphony Pumpset usability
Time Frame: day at inclusion
Rating of the Usability of the Symphony Pumpset
day at inclusion
Usability Scale (SUS) BrownieForSymphony Pumpset usability
Time Frame: after 5 days
Rating of the Usability of the BrownieForSymphony Pumpset
after 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medela AG

Investigators

  • Principal Investigator: Danielle Prime, PhD, Medela AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MBF1502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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