Evaluation of the Reliability and Usability of the Reusab... | NCT02492139

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

NCT02492139

Sponsor

Medela AG

Status

Completed

Last Update Posted

Feb 10, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Lactation

Interventions

Pumping CE-marked Symphony Pumpset
Pumping BrownieForSymphony Pumpset

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jul 1, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2020

Last Update Posted Date

Feb 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pumping CE-marked Symphony Pumpset	Device	Pumping with the CE-marked Symphony Pumpset	Pumping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
User experience questionnaire (UEQ)		after 7 days, 14 days, 3 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole Steinfelder	Medela AG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medela AG		Baar	Canton of Zug	6341	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided