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

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 Overview

• Status: Completed
• Conditions: Breast Pumping
• Intervention / Treatment: Device: Breast Pump

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Baar, Switzerland, 6431
    • Medela AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Hydraulic Breast pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recording all Adverse Events	Recording all AE and evaluating the (time of) occurrence, type, seriousness, expectedness, relatedness, and outcome of the adverse events	3 months
Observing pump performance	Measuring milk flow volume including time to first ejection.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measureing user acceptance	Analysing the User Experience Questionnaire as per Laugwitz, Held & Schrepp (2017)	3 months

Collaborators and Investigators

• Sponsor: Medela AG
• Investigators: Principal Investigator: Beatrix Mascher, MBA, Clinical Affairs within Medical Reseach and R&D

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MHM1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No