MedTrace Logo

Influence of the Brownie Breast Shield on the Dynamics of Milk Removal

NCT03091985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-02-10

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy of breast drainage of the healthy breast with the new Medela pump set breast shield (Brownie).

The objective of the study is to verify the Brownie breast shield to be non-inferior to the current PersonalFit breast shield in emptying the healthy lactating breast.

Conditions

  • Lactation

Interventions

DEVICE

PersonalFit - Breast shield

Subjects are to pump 15 min with the comparator device

DEVICE

Brownie - Breast shield

Subjects are to pump 15 min with the investigational device

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • Medela AG

    lead INDUSTRY

Principal Investigators

  • Lennart Ivarsson, PhD · Employee

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-09-30
Completion
2017-12-19

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091985 on ClinicalTrials.gov