NCT02542527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 10, 2020

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 2, 2015

Last Update Submit

February 7, 2020

Conditions

Lactation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pumping with a fluid filled breast pump

EXPERIMENTAL

Participants pump (each breast 25 min) with the new fluid filled breast pump

Procedure: Fluid filled breast pump

Interventions

Fluid filled breast pumpPROCEDURE

breast milk pumping with a fluid filled breast pump

Pumping with a fluid filled breast pump

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medela AG

Baar, Canton of Zug, 6341, Switzerland

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Danielle Prime, PhD

    Medela Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 10, 2020

Record last verified: 2015-10

Locations

CH(1)