NCT05222581

Engineering Evaluation of a Breast Pump Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Momtech Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Breast Pumping

Interventions

Type	Name	Description
DEVICE	Prototypes of breast shield and Freedom Double Electric Breast Pump	Prototypes of breast shield and Freedom Double Electric Breast Pump.

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-06-01
• Completion: 2024-09-30
• First posted: 2022-02-03
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study