LactationC88NCT02542527
Evaluation of the Functionality of a Fluid Filled Single Breast Pump
A study testing Fluid filled breast pump in people with Lactation, run by Medela AG at 1 site in Switzerland.
Trial summary
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects. 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?
- Fluid filled breast pump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Oct 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
- Female over 18 years
- Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
- The participant is pumping at least 2 times a week
- The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
- The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
- The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
- The participant agrees to photograph and video record the breast and upper body (no face)
- The participant agrees to the presence of up to 3 men in the room during the pumping session
Who cannot join
- Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
- Participant has an medical condition of the breast
- Participant is allergic to plastics or silicone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.
- Conditions
- Lactation
- Being tested
- Fluid filled breast pump
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid filled breast pumpProcedure or surgery
breast milk pumping with a fluid filled breast pump
| Study group | Role | What they receive |
|---|---|---|
| Pumping with a fluid filled breast pump | Experimental | Participants pump (each breast 25 min) with the new fluid filled breast pump Receives: Procedure: Fluid filled breast pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast pump vacuum (mmHg)
Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes.
Measured: Measured during a single 25 minute pumping session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Prime, PhD, Principal investigator, Medela Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542527
- Sponsor's protocol ID
- MBF1504
- Acronym
- C88
- Status last verified
- Oct 2015
- First submitted
- 2 Sep 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
- C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast
- ClinicalTrials.gov ID
- NCT02542527
- Acronym / sponsor ID
- C88 / MBF1504
- Conditions
- Lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Sep 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.
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pumping with a fluid filled breast pump | Experimental | Procedure: Fluid filled breast pumpParticipants pump (each breast 25 min) with the new fluid filled breast pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female over 18 years
- Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
- The participant is pumping at least 2 times a week
- The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
- The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
Key exclusion criteria (3 listed)
- Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
- Participant has an medical condition of the breast
- Participant is allergic to plastics or silicone
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 |
|---|---|---|
| Fluid filled breast pumpbreast milk pumping with a fluid filled breast pump | Procedure or surgery | Pumping with a fluid filled breast pump |
Primary outcome
Breast pump vacuum (mmHg)
Time frame: Measured during a single 25 minute pumping session
Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes.
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.
Danielle Prime, PhD principal investigator
Medela Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid filled breast pump 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 8 inclusion and 3 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?
Breast pump vacuum (mmHg) (time frame: Measured during a single 25 minute pumping session). 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.