CompletedNot Applicable

Engineering Evaluation of a Breast Pump Device

United States48 participantsStarted 2022-01-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Breast shield comfort

Timeframe: 1 day (Single timepoint)

Breast shield fit

Timeframe: 1 day (Single timepoint)

Breast shield ease of use

Timeframe: 1 day (Single timepoint)

Trial details

NCT IDNCT05222581

SponsorMomtech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.