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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02496429
Acronym
ESP
Enrollment
25
Registered
2015-07-14
Start date
2015-07-31
Completion date
2015-09-30
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation

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

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.

Interventions

DEVICEBrownieForSymphony use

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

Sponsors

Medela AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Usability Scale (SUS) Symphony Pumpset usabilityday at inclusionRating of the Usability of the Symphony Pumpset
Usability Scale (SUS) BrownieForSymphony Pumpset usabilityafter 5 daysRating of the Usability of the BrownieForSymphony Pumpset

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026