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

Medela AG1 site in 1 country4 target enrollmentSeptember 2015

ConditionsLactation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lactation
Sponsor: Medela AG
Enrollment: 4
Locations: 1
Primary Endpoint: Breast pump vacuum (mmHg)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

October 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Medela AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.