Evaluation of Fluid-Filled Expression Core Technology Study - I

NCT03921918 | Completed

• 1 other identifier: MHM1801
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Measureing user acceptance

  3 months

Study Arms (1)

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

Device: Breast Pump

Interventions

Breast Pump DEVICE

Hydraulic Breast pump

Evaluation of Fluid Expression Technology

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medela AG: lead

Study Sites (1)

Medela AG

Baar, 6431, Switzerland

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Beatrix Mascher, MBA

  Clinical Affairs within Medical Reseach and R&D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 19, 2019
• Study Start: May 8, 2019
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: February 10, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)