Breast PumpingEffect-1NCT03921918
Evaluation of Fluid-Filled Expression Core Technology Study - I
A study testing Breast Pump in people with Breast Pumping, run by Medela AG at 1 site in Switzerland.
Trial summary
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump… 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
- Breast Pumping
- What is being tested?
- Breast Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 May 2019to 7 Nov 2019
- 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
- Subject ≥ 18 years old
- Infant is ≥1 and ≤6 month old
- Subject and baby are healthy according to self-declaration in the "Mother and infant health questionnaire"
- Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
- The subject agrees to pump or feed the last time a minimum of 2 hours (hr) before the start of the pumping session at the study site
- The subject agrees to photographs/3 D scan of the breast and upper body (no face),
Show all 10Show fewer
- The subject agrees to a video while pumping
- The subject signs the informed consent documentation
- Subject agrees that a maximum of 2 male team members can be present in the room to conduct the usability part of the study
- The mother accepts that the pumped milk in visit 2 must be donated to the study i.e. cannot be fed to the baby
Who cannot join
- The subject has a nipple size ≥ 21 mm
- Mastitis (any breast within two weeks prior to enrolment)
- Engorgement (any breast within two weeks prior to enrolment).
- Case of current infection as self-declared in the Mother and infant health questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
Read the detailed description
Current breast pumps function in a way that is different to breastfeeding. These include the seal to the breast, the movement of the nipple, the sensations of warmth and moisture, the variability in frequency, and the strength of the applied vacuum. During breastfeeding the mother's nipple and the infant's mouth form a chamber that is a fluid-filled, no dead volume system, which is needed to create a working vacuum to remove milk from the breast. There is no air visible in the natural system according to ultrasound measurements. This is unlike breast pumps which use an air-filled, large dead volume system, to create a working vacuum. Therefore, a functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
- Conditions
- Breast Pumping
- Being tested
- Breast Pump
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast PumpDevice
Hydraulic Breast pump
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Fluid Expression Technology | Other | This study aims to provide important insights with respect to the safety, performance, and real-life usability of pumping technology Receives: Device: Breast Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording all Adverse Events
Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events
Measured: 3 months
Observing pump performance
Measuring milk flow volume including time to first ejection.
Measured: 3 months
Secondary outcomes (1)
Measureing user acceptance
Analysing the User Experience Questionnaire as per Laugwitz, Held \& Schrepp (2017)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start8 May 2019
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PumpingStudies 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
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beatrix Mascher, MBA, Principal investigator, Clinical Affairs within Medical Reseach and R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921918
- Sponsor's protocol ID
- MHM1801
- Acronym
- Effect-1
- Status last verified
- Nov 2019
- First submitted
- 11 Apr 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Evaluation of Fluid-Filled Expression Core Technology Study - I
- ClinicalTrials.gov ID
- NCT03921918
- Acronym / sponsor ID
- Effect-1 / MHM1801
- Conditions
- Breast Pumping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- 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.
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
Detailed description
Current breast pumps function in a way that is different to breastfeeding. These include the seal to the breast, the movement of the nipple, the sensations of warmth and moisture, the variability in frequency, and the strength of the applied vacuum. During breastfeeding the mother's nipple and the infant's mouth form a chamber that is a fluid-filled, no dead volume system, which is needed to create a working vacuum to remove milk from the breast. There is no air visible in the natural system according to ultrasound measurements. This is unlike breast pumps which use an air-filled, large dead volume system, to create a working vacuum. Therefore, a functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Fluid Expression Technology | Other | Device: Breast PumpThis study aims to provide important insights with respect to the safety, performance, and real-life usability of pumping technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject ≥ 18 years old
- Infant is ≥1 and ≤6 month old
- Subject and baby are healthy according to self-declaration in the "Mother and infant health questionnaire"
- Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
- The subject agrees to pump or feed the last time a minimum of 2 hours (hr) before the start of the pumping session at the study site
Key exclusion criteria (4 listed)
- The subject has a nipple size ≥ 21 mm
- Mastitis (any breast within two weeks prior to enrolment)
- Engorgement (any breast within two weeks prior to enrolment).
- Case of current infection as self-declared in the Mother and infant health questionnaire
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 |
|---|---|---|
| Breast PumpHydraulic Breast pump | Device | Evaluation of Fluid Expression Technology |
Primary outcome
Recording all Adverse Events
Time frame: 3 months
Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events
Observing pump performance
Time frame: 3 months
Measuring milk flow volume including time to first ejection.
1 secondary outcome
Measureing user acceptance
Time frame: 3 months
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.
- Individual participant dataSharing planned: No
Related trials for Breast Pumping
Not yet recruitingPhase 1
A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy Participants
Healthy Participants, Gastrointestinal Neoplasms
RecruitingPhase 4
Postpartum Vaginal Estrogen for Breastfeeding Patients
Breastfeeding, Postpartum Sexual Dysfunction
Not yet recruiting
The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
Preterm Birth
Recruiting
Pumping to Up Maternal Milk Production for Preterms
Breastfeeding, Breastmilk Expression
Recruiting
Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production
Low Milk Supply
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.
Beatrix Mascher, MBA principal investigator
Clinical Affairs within Medical Reseach and R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Pump in people with Breast Pumping, 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 10 inclusion and 4 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?
Recording all Adverse Events (time frame: 3 months). 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.