LactationESPIINCT02492139
Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
A study testing Pumping CE-marked Symphony Pumpset and Pumping BrownieForSymphony Pumpset in people with Lactation, run by Medela AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Pumping CE-marked Symphony Pumpset and Pumping BrownieForSymphony Pumpset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- o Woman has a medical condition of the breast (eg. Mastitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
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
- Being tested
- Pumping CE-marked Symphony Pumpset, Pumping BrownieForSymphony Pumpset
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumping CE-marked Symphony PumpsetDevice
Pumping with the CE-marked Symphony Pumpset
Pumping BrownieForSymphony PumpsetDevice
Pumping with the the BrownieForSymphony Pumpset
| Study group | Role | What they receive |
|---|---|---|
| Pumping | Other | Each particpant will pump with the current pumpset one week and then two weeks with the pumpset Receives: Device: Pumping CE-marked Symphony Pumpset; Device: Pumping BrownieForSymphony Pumpset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability Scale (SUS) Symphony Pumpset usability
Rating of the Usability of the Symphony Pumpset
Measured: after 7 days
Usability Scale (SUS) BrownieForSymphony Pumpset usability
Rating of the Usability of the Symphony Pumpset
Measured: after 14 days
Secondary outcomes (1)
User experience questionnaire (UEQ)
Measured: after 7 days, 14 days, 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Steinfelder, Principal investigator, Medela AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492139
- Sponsor's protocol ID
- MBF1503
- Acronym
- ESPII
- Status last verified
- Feb 2020
- First submitted
- 1 Jul 2015
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
- ClinicalTrials.gov ID
- NCT02492139
- Acronym / sponsor ID
- ESPII / MBF1503
- Conditions
- Lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pumping | Other | Device: Pumping CE-marked Symphony Pumpset, Device: Pumping BrownieForSymphony PumpsetEach particpant will pump with the current pumpset one week and then two weeks with the pumpset |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lactating woman >18 years who
Key exclusion criteria (1 listed)
- o Woman has a medical condition of the breast (eg. Mastitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pumping CE-marked Symphony PumpsetPumping with the CE-marked Symphony Pumpset | Device | Pumping |
| Pumping BrownieForSymphony PumpsetPumping with the the BrownieForSymphony Pumpset | Device | Pumping |
Primary outcome
Usability Scale (SUS) Symphony Pumpset usability
Time frame: after 7 days
Rating of the Usability of the Symphony Pumpset
Usability Scale (SUS) BrownieForSymphony Pumpset usability
Time frame: after 14 days
Rating of the Usability of the Symphony Pumpset
1 secondary outcome
User experience questionnaire (UEQ)
Time frame: after 7 days, 14 days, 3 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Steinfelder principal investigator
Medela AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumping CE-marked Symphony Pumpset and Pumping BrownieForSymphony Pumpset in people with Lactation, run by Medela AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Scale (SUS) Symphony Pumpset usability (time frame: after 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.