Evaluation of the Reliability and Usability of the Reusab... | NCT02496429

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

NCT02496429

Sponsor

Medela AG

Status

Completed

Last Update Posted

Feb 10, 2020Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Lactation

Interventions

BrownieForSymphony use

Countries

Germany

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

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jul 8, 2015

First Submission Date that Met QC Criteria

Jul 10, 2015

First Posted Date

Jul 14, 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 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.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BrownieForSymphony use	Other	Each participant will use the BrownieForSymphony pumpset	Device: BrownieForSymphony use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BrownieForSymphony use	Device	Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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
Danielle Prime, PhD	Medela AG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Dr. Geißenhofer		Munich		80538	Germany
University Tuebingen

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