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Evaluation of Fluid-Filled Expression Core Technology Study - I (Effect-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921918
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Medela AG

Study Description
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Brief 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, disassemble, clean and reuse.

Condition or disease Intervention/treatment Phase
Breast Pumping Device: Breast Pump Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Fluid-Filled Expression Core Technology Study - I
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019
Arms and Interventions
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Arm Intervention/treatment
Evaluation of Fluid Expression Technology
This study aims to provide important insights with respect to the safety, performance, and real-life usability of pumping technology
 Device: Breast Pump
Hydraulic Breast pump


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Observing pump performance [ Time Frame: 3 months ]
    Measuring milk flow volume including time to first ejection.


Secondary Outcome Measures :
  1. Measureing user acceptance [ Time Frame: 3 months ]
    Analysing the User Experience Questionnaire as per Laugwitz, Held & Schrepp (2017)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject ≥ 18 years old
  2. Infant is ≥1 and ≤6 month old
  3. Subject and baby are healthy according to self-declaration in the "Mother and infant health questionnaire"
  4. Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
  5. 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
  6. The subject agrees to photographs/3 D scan of the breast and upper body (no face),
  7. The subject agrees to a video while pumping
  8. The subject signs the informed consent documentation
  9. Subject agrees that a maximum of 2 male team members can be present in the room to conduct the usability part of the study
  10. The mother accepts that the pumped milk in visit 2 must be donated to the study i.e. cannot be fed to the baby

Exclusion Criteria:

  1. The subject has a nipple size ≥ 21 mm
  2. Mastitis (any breast within two weeks prior to enrolment)
  3. Engorgement (any breast within two weeks prior to enrolment).
  4. Case of current infection as self-declared in the Mother and infant health questionnaire
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921918


Locations
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Switzerland
Medela AG
Baar, Switzerland, 6431
Sponsors and Collaborators
Medela AG
Investigators
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Principal Investigator: Beatrix Mascher, MBA Clinical Affairs within Medical Reseach and R&D
More Information
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Responsible Party: Medela AG
ClinicalTrials.gov Identifier: NCT03921918    
Other Study ID Numbers: MHM1801
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No