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Breast Pump Device for Breast Pumping in Healthy Subjects

N/A
Recruiting
Led By Ashley Wofford Leong, MD
Research Sponsored by Momtech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day (single visit)
Awards & highlights

Study Summary

This trial is testing a new electric breast pump design to see if it works well. The study will not test health outcomes.

Who is the study for?
This trial is for healthy breastfeeding individuals who are not currently pregnant, have no breast or nipple injuries, infections, or piercings, and haven't had breast surgery. Participants must be using an electric breast pump regularly and willing to attend five testing visits over 3-4 months while continuing to breastfeed.Check my eligibility
What is being tested?
The study is evaluating the design of a new electric breast pump device by having participants use prototypes of a breast shield and Freedom Double Electric Breast Pump. The focus is on assessing the feasibility of these designs through multiple testing sessions.See study design
What are the potential side effects?
Since this trial is for engineering evaluation purposes rather than health outcomes, specific side effects related to health aren't anticipated. However, discomfort from using different prototype devices may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently breastfeeding and plan to continue for the next 3 to 4 months.
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You are using an electric breast pump frequently.
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You must have a history of being in good health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day (single visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day (single visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast shield comfort
Breast shield ease of use
Breast shield fit
Secondary outcome measures
Participant comparison of device to breastfeeding
Participant comparison of device to current commercial breast pump
Volume of milk expressed

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prototypes of Breast Shield and Freedom Double Electric Breast PumpExperimental Treatment1 Intervention
Prototypes of breast shield and Freedom Double Electric Breast Pump

Find a Location

Who is running the clinical trial?

Momtech Inc.Lead Sponsor
Ashley Wofford Leong, MDPrincipal InvestigatorIndependent Physician
Sarah Adams, MDPrincipal InvestigatorIndependent Physician
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Prototypes of breast shield and Freedom Double Electric Breast Pump Clinical Trial Eligibility Overview. Trial Name: NCT05222581 — N/A
Breast Pumping Research Study Groups: Prototypes of Breast Shield and Freedom Double Electric Breast Pump
Breast Pumping Clinical Trial 2023: Prototypes of breast shield and Freedom Double Electric Breast Pump Highlights & Side Effects. Trial Name: NCT05222581 — N/A
Prototypes of breast shield and Freedom Double Electric Breast Pump 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222581 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this trial?

"Affirmative. Clinicaltrials.gov indicates that this medical experiment, which was first shared on January 19th 2022, is actively searching for test subjects. Approximately 20 individuals must be recruited from 1 centre."

Answered by AI

Are there still opportunities to participate in this trial?

"Affirmative. The clinical trial portal reveals that this medical research, which was initially posted on January 19th 2022, is now recruiting patients. 20 new participants are expected to be assembled from a single clinic location."

Answered by AI
~4 spots leftby Sep 2024