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

NCT02492139 | Completed

• 1 other identifier: MBF1503
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Usability Scale (SUS) Symphony Pumpset usability

  Rating of the Usability of the Symphony Pumpset

  after 7 days

• Usability Scale (SUS) BrownieForSymphony Pumpset usability

  Rating of the Usability of the Symphony Pumpset

  after 14 days

Secondary Outcomes (1)

• User experience questionnaire (UEQ)

  after 7 days, 14 days, 3 week

Study Arms (1)

Pumping

OTHER

Each particpant will pump with the current pumpset one week and then two weeks with the pumpset

Device: Pumping CE-marked Symphony Pumpset; Device: Pumping BrownieForSymphony Pumpset

Interventions

Pumping CE-marked Symphony Pumpset DEVICE

Pumping with the CE-marked Symphony Pumpset

Pumping

Pumping BrownieForSymphony Pumpset DEVICE

Pumping with the the BrownieForSymphony Pumpset

Pumping

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lactating woman \>18 years who
• Have been pumping for at least 7 days with the Symphony pump and pump set prior to study participation
• Have been pumping at least 10 times in the week prior to study participation
• Consistently pump 10 ml of milk or more per breast, per pumping session prior to study participation
• Currently use a breast shield size of 24 mm
• Participant has agreed to pump at least 10 times a week over the next three weeks

You may not qualify if:

• o Woman has a medical condition of the breast (eg. Mastitis)

Sponsors & Collaborators

• Medela AG: lead

Study Sites (1)

Medela AG

Baar, Canton of Zug, 6341, Switzerland

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Nicole Steinfelder

  Medela AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

CH (1)