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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medtronic PSR TDD PMCF

NCT04714385

Chronic Pain Spasticity, Muscle

COMPLETED

Clinical Evaluation of New Computerized Labor Monitoring System

NCT00496899

Obstetrics Labor

TERMINATED

ElastoMeric Infusion Pumps for Hospital AntibioTICs

NCT05150015

Infection, Bacterial

COMPLETED NA

SynchroMed II Post-Approval Study

NCT00773019

Severe Spasticity Chronic Pain

COMPLETED

Assessing Patient Preference for Infusion Systems

NCT07189013

Primary Immunodeficiencies (PID) Secondary Immunodeficiencies (SID)

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lactation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pumping

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

Group Type OTHER

Pumping CE-marked Symphony Pumpset

Intervention Type DEVICE

Pumping with the CE-marked Symphony Pumpset

Pumping BrownieForSymphony Pumpset

Intervention Type DEVICE

Pumping with the the BrownieForSymphony Pumpset

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pumping CE-marked Symphony Pumpset

Pumping with the CE-marked Symphony Pumpset

Intervention Type DEVICE

Pumping BrownieForSymphony Pumpset

Pumping with the the BrownieForSymphony Pumpset

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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