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

Medela

Status: Completed

Conditions: Lactation

Treatments: Device: BrownieForSymphony use

Study type: Interventional

Funder types: Industry

Identifiers

NCT02496429

MBF1502

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

BrownieForSymphony use

Other group

Description:

Each participant will use the BrownieForSymphony pumpset

Treatment:

Device: BrownieForSymphony use