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Can a wearable sensor read breast fullness and milk flow?

NCT ID NCT07800078

Knowledge-focused Sponsor: Özlem Ülkü BULUT Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are testing a wearable sensor prototype, paired with a mobile app, that aims to measure breast fullness and milk flow during breastfeeding or pumping. The study will compare the sensor's readings with the actual amount of milk expressed during pumping sessions. It will also ask breastfeeding women about their experiences, satisfaction, and how easy the device is to use. The technology is meant for monitoring and support only, not for diagnosis or treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A wearable sensor prototype with a mobile app that tracks breast fullness and milk flow during breastfeeding or pumping
What this could lead to
If the sensors prove accurate and women find the device easy and useful, it could become a practical tool to help breastfeeding mothers monitor milk supply and feeding patterns at home.
What could go wrong
This is a small, early feasibility study with 36 participants, so results may not apply to all women. The device is for monitoring only, not diagnosis or treatment, and sensor accuracy may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women aged 18-45 years * Currently breastfeeding * Having an infant aged 0-6 months * Willing to use the wearable technology and accompanying mobile application for 15 days * Able to express breast milk for comparison with sensor measurements * Voluntarily agreeing to participate in the study Exclusion Criteria: * Having a medical condition that prevents breastfeeding or breast milk expression * Having an active breast or nipple condition that prevents the use of the wearable prototype * Being unable to use the wearable technology or mobile application during the study period * Withdrawing consent at any stage of the study

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfeeding

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Lokman Hekim University

    Ankara, Ankara, 06300, Turkey (Türkiye)

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