NCT02496429

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

July 8, 2015

Last Update Submit

February 7, 2020

Conditions

Lactation

Outcome Measures

Primary Outcomes (2)

  • Usability Scale (SUS) Symphony Pumpset usability

    Rating of the Usability of the Symphony Pumpset

    day at inclusion

  • Usability Scale (SUS) BrownieForSymphony Pumpset usability

    Rating of the Usability of the BrownieForSymphony Pumpset

    after 5 days

Study Arms (1)

BrownieForSymphony use

OTHER

Each participant will use the BrownieForSymphony pumpset

Device: BrownieForSymphony use

Interventions

BrownieForSymphony useDEVICE

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

BrownieForSymphony use

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized lactating woman \>18 years which are pumping breast milk

You may not qualify if:

  • hospitalized lactating woman has a medical indication for pumping (e.g. Mastitis, cracked nipples) lactating woman used a breast shield size \>27 and \<24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik Dr. Geißenhofer

Munich, 80538, Germany

Location

University Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Danielle Prime, PhD

    Medela AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

DE(2)