Prototypes of breast shield and Freedom Double Electric Breast Pump for Breast Pumping

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Pumping+1 MorePrototypes of breast shield and Freedom Double Electric Breast Pump - Device
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Breast Pumping
  • Healthy Subjects

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Text message including biomarker of breast pumping adequacy
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LYBALVI
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Safe Home Text Message Reminders

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 1 day (single visit)

1 day (Single Timepoint)
Volume of milk expressed
1 day (Single timepoint)
Breast shield comfort
Breast shield ease of use
Breast shield fit
1 day (single timepoint)
Participant comparison of device to current commercial breast pump
1 day (single visit)
Participant comparison of device to breastfeeding

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Text message including biomarker of breast pumping adequacy
1
LYBALVI
2
Safe Home Text Message Reminders

Trial Design

1 Treatment Group

Prototypes of Breast Shield and Freedom Double Electric Breast Pump
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Prototypes of breast shield and Freedom Double Electric Breast Pump · No Placebo Group · N/A

Prototypes of Breast Shield and Freedom Double Electric Breast Pump
Device
Experimental Group · 1 Intervention: Prototypes of breast shield and Freedom Double Electric Breast Pump · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 day (single visit)

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently breastfeeding and plan to continue breastfeeding for the next 3 to 4 months.
You are currently using a commercial electric breast pump at least several times a week.
You have sufficient milk supply for one missed infant feeding per device testing visit.
You are willing to attend five device testing visits over 3 to 4 months.
You are willing to discard milk collected during testing.
References

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