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CompletedNCT03921918Effect-1Updated Feb 10, 2020

Evaluation of Fluid-Filled Expression Core Technology Study - I

An interventional study of Breast Pump in Breast Pumping, sponsored by Medela AG. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Medela AG · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Breast Pumping
03

In context

Lead sponsor

Medela AG is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    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

Interventions

  • DeviceBreast Pump

    Hydraulic Breast pump

06

What researchers measure

Primary outcomes

  1. Recording all Adverse Events

    Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events

    Time frame: 3 months

  2. Observing pump performance

    Measuring milk flow volume including time to first ejection.

    Time frame: 3 months

Secondary outcomes

  1. Measureing user acceptance

    Analysing the User Experience Questionnaire as per Laugwitz, Held \& Schrepp (2017)

    Time frame: 3 months

07

Study locations

1 site
  • Medela AG
    Baar, 6431, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03921918
Lead sponsor
Medela AG
Responsible party
Sponsor
First posted
Apr 19, 2019
Start date
May 8, 2019
Primary completion
Nov 7, 2019
Completion
Nov 7, 2019
Last update
Feb 10, 2020

Study contacts

Beatrix Mascher, MBA
principal investigator · Clinical Affairs within Medical Reseach and R&D

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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