Evaluation of the Functionality of a Fluid Filled Single Breast Pump

Lactation Clinical Trial

— C88  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542527
• Other study ID #: MBF1504
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Intervention

Procedure:
• Fluid filled breast pump
breast milk pumping with a fluid filled breast pump

Locations

Country	Name	City	State
Switzerland	Medela AG	Baar	Zug

Sponsors (1)

Lead Sponsor	Collaborator
Medela AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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