HealthyNCT05222581
Engineering Evaluation of a Breast Pump Device
A study testing Prototypes of breast shield and Freedom Double Electric Breast Pump in people with Healthy and Breast Pumping, run by Momtech Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Breast Pumping
- What is being tested?
- Prototypes of breast shield and Freedom Double Electric Breast Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Blur Product Development
Cary, North Carolina, 27513
About this study
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.
Read the 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
- Being tested
- Prototypes of breast shield and Freedom Double Electric Breast Pump
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototypes of breast shield and Freedom Double Electric Breast PumpDevice
Prototypes of breast shield and Freedom Double Electric Breast Pump.
| Study group | Role | What they receive |
|---|---|---|
| Prototypes of Breast Shield and Freedom Double Electric Breast Pump | Experimental | Prototypes of breast shield and Freedom Double Electric Breast Pump Receives: Device: Prototypes of breast shield and Freedom Double Electric Breast Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast shield comfort
Rate comfort of device by Questionnaire
Measured: 1 day (Single timepoint)
Breast shield fit
Rate fit of device by Questionnaire
Measured: 1 day (Single timepoint)
Breast shield ease of use
Rate ease of use of device by Questionnaire
Measured: 1 day (Single timepoint)
Secondary outcomes (3)
Volume of milk expressed
Rate volume of milk expressed with device by Questionnaire
Measured: 1 day (Single Timepoint)
Participant comparison of device to current commercial breast pump
Rate comparison of device to current breast pump experience by Questionnaire
Measured: 1 day (single timepoint)
Participant comparison of device to breastfeeding
Rate comparison of device to breastfeeding experience by Questionnaire
Measured: 1 day (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start19 Jan 2022
- Primary completion1 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prototype breast shield designs for the Freedom Double Electric Breast Pump with \<10 subjects per breast shield design. The study sample size is appropriate for a small feasibility study evaluating design concepts because there are several breast shield designs being evaluated with a small number of subjects per design.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momtech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Wofford Leong, MD, Principal investigator, Independent Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222581
- Sponsor's protocol ID
- MOMI-001
- Status last verified
- May 2025
- First submitted
- 11 Jan 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Evaluation of a Breast Pump Device
- ClinicalTrials.gov ID
- NCT05222581
- Acronym / sponsor ID
- MOMI-001
- Conditions
- Healthy, Breast Pumping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Momtech Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prototype breast shield designs for the Freedom Double Electric Breast Pump with <10 subjects per breast shield design. The study sample size is appropriate for a small feasibility study evaluating design concepts because there are several breast shield designs being evaluated with a small number of subjects per design.
| Arm | Type | Receives |
|---|---|---|
| Prototypes of Breast Shield and Freedom Double Electric Breast Pump | Experimental | Device: Prototypes of breast shield and Freedom Double Electric Breast PumpPrototypes of breast shield and Freedom Double Electric Breast Pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototypes of breast shield and Freedom Double Electric Breast PumpPrototypes of breast shield and Freedom Double Electric Breast Pump. | Device | Prototypes of Breast Shield and Freedom Double Electric Breast Pump |
Primary outcome
Breast shield comfort
Time frame: 1 day (Single timepoint)
Rate comfort of device by Questionnaire
Breast shield fit
Time frame: 1 day (Single timepoint)
Rate fit of device by Questionnaire
Breast shield ease of use
Time frame: 1 day (Single timepoint)
Rate ease of use of device by Questionnaire
3 secondary outcomes
Volume of milk expressed
Time frame: 1 day (Single Timepoint)
Participant comparison of device to current commercial breast pump
Time frame: 1 day (single timepoint)
Participant comparison of device to breastfeeding
Time frame: 1 day (single visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Wofford Leong, MD principal investigator
Independent Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototypes of breast shield and Freedom Double Electric Breast Pump in people with Healthy and Breast Pumping, run by Momtech Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast shield comfort (time frame: 1 day (Single timepoint)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.