Engineering Evaluation of a Breast Pump Device

RECRUITING

I'm interested ...!!

This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.

Conditions:

🦠 Healthy 🦠 Breast Pumping

🗓️ Study Start (Actual) 19 January 2022

🗓️ Primary Completion (Estimated) 30 September 2024

✅ Study Completion (Estimated) 30 November 2024

👥 Enrollment (Estimated) 20

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Cary, North Carolina, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* History of good health
* Currently lactating and planning to continue breastfeeding for the next 3 to 4 months
* Currently using a commercial electric breast pump at least several times a week
* Sufficient milk supply for one missed infant feeding per device testing visit
* Willing to attend five device testing visits over 3 to 4 months
* Willing to be video recorded during device testing
* Willing to discard milk collected during testing

Exclusion Criteria:

* No active breast or nipple injury, breast inflammation or infection, or nipple piercing
* No prior history of breast implant, reduction or reconstruction surgery
* Not currently pregnant

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 11 January 2022
First Submitted that Met QC Criteria 24 January 2022
First Posted 3 February 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 11 March 2024
Last Update Posted 13 March 2024
Last Verified March 2024