NCT03921918

Evaluation of Fluid-Filled Expression Core Technology Study - I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Medela AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Breast Pump	Hydraulic Breast pump

Timeline

• Start date: 2019-05-08
• Primary completion: 2019-11-07
• Completion: 2019-11-07
• First posted: 2019-04-19
• Last updated: 2020-02-10

Locations

1 site across 1 country: Switzerland