What side effects are associated with this type of intervention?

The use of mechanical devices such as electric breast pumps for the extraction of breast milk generally has minimal side effects. Commonly reported side effects include mild discomfort, nipple pain, and breast tissue soreness. In rare cases, improper use can lead to nipple damage or breast infections. It is important for users to follow the manufacturer's instructions and maintain proper hygiene to minimize these risks.

What prior FDA approvals exist?

The FDA has approved various devices and treatments that assist in physiological processes through mechanical means. For example, electric breast pumps, which are designed to aid lactating women in the extraction of breast milk, have been approved for their efficacy and safety. These devices typically use electric power to create suction, mimicking the natural breastfeeding process to facilitate milk expression. While specific FDA approvals for electric breast pumps were not detailed in the provided context, these devices are widely recognized and regulated to ensure they meet health and safety standards for both mothers and infants.

What other types of research exist?

Promising novel alternatives to electric breast pumps for 2024 may include wearable breast pumps, which offer greater mobility and convenience, and manual breast pumps, which are non-electric and can be more affordable and portable. Additionally, advancements in hands-free and smart breast pumps that integrate with mobile apps for monitoring and tracking milk production could provide enhanced user experience and efficiency.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day (single visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new electric breast pump with breastfeeding women to see if it fits well, is comfortable, and easy to use.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day (single visit)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Breast shield comfort

Breast shield ease of use

Breast shield fit

Secondary study objectives

Participant comparison of device to breastfeeding

Participant comparison of device to current commercial breast pump

Volume of milk expressed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The electric breast pump operates by creating a vacuum that mimics a baby's suckling, stimulating milk flow from the breast. This mechanism is important for healthy lactating mothers as it enables efficient milk extraction, helps maintain milk supply, relieves engorgement, and allows for milk storage. This is particularly beneficial for mothers who need to be away from their infants or face challenges with direct breastfeeding.

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