Evaluation of the Functionality of a Fluid Filled Single Breast Pump (C88)

C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast

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.

Study Overview

• Status: Completed
• Conditions: Lactation
• Intervention / Treatment: Procedure: Fluid filled breast pump

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zug
    • Baar, Zug, Switzerland, 6341
      • 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:

• Female over 18 years
• Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
• The participant is pumping at least 2 times a week
• The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
• The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
• The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
• The participant agrees to photograph and video record the breast and upper body (no face)
• The participant agrees to the presence of up to 3 men in the room during the pumping session

Exclusion criteria:

• Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
• Participant has an medical condition of the breast
• Participant is allergic to plastics or silicone

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
Experimental: Pumping with a fluid filled breast pump; Participants pump (each breast 25 min) with the new fluid filled breast pump	Procedure: Fluid filled breast pump; breast milk pumping with a fluid filled breast pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast pump vacuum (mmHg)	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.	Measured during a single 25 minute pumping session

Collaborators and Investigators

• Sponsor: Medela AG
• Investigators: Principal Investigator: Danielle Prime, PhD, Medela Switzerland

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MBF1504