Evaluation of the Functionality of a Fluid Filled Single Breast Pump

Not Applicable

Completed

• Conditions: Lactation
• Interventions: Procedure: Fluid filled breast pump

• Registration Number: NCT02542527
• Lead Sponsor: Medela AG

Brief Summary

This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pumping with a fluid filled breast pump	Fluid filled breast pump	Participants pump (each breast 25 min) with the new fluid filled breast pump

Primary Outcome Measures

Name	Time	Method
Breast pump vacuum (mmHg)	Measured during a single 25 minute pumping session	Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes.

Trial Locations

Locations (1)

Medela AG; 🇨🇭 Baar, Zug, Switzerland