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Completed

NCT Number: NCT02542527

Evaluation of the Functionality of a Fluid Filled Single Breast Pump

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.

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Key information

Conditions

Lactation Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medela AG

Baar, Canton of Zug, 6341, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid filled breast pump

Procedure

breast milk pumping with a fluid filled breast pump

Primary outcomes

  1. Breast pump vacuum (mmHg)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Registry information

Official study 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

Acronym: C88

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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