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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05222581
Other study ID # MOMI-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2022
Est. completion date November 30, 2024

Study information

Verified date March 2024
Source Momtech Inc.
Contact Research Coordinator
Phone 919-257-1769
Email ccoleman@blurpd.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Prototypes of breast shield and Freedom Double Electric Breast Pump
Prototypes of breast shield and Freedom Double Electric Breast Pump.

Locations

Country Name City State
United States Blur Product Development Cary North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Momtech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Breast shield comfort Rate comfort of device by Questionnaire 1 day (Single timepoint)
Primary Breast shield fit Rate fit of device by Questionnaire 1 day (Single timepoint)
Primary Breast shield ease of use Rate ease of use of device by Questionnaire 1 day (Single timepoint)
Secondary Volume of milk expressed Rate volume of milk expressed with device by Questionnaire 1 day (Single Timepoint)
Secondary Participant comparison of device to current commercial breast pump Rate comparison of device to current breast pump experience by Questionnaire 1 day (single timepoint)
Secondary Participant comparison of device to breastfeeding Rate comparison of device to breastfeeding experience by Questionnaire 1 day (single visit)
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