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C-Section blood loss monitor shows promise in tiny trial

NCT ID NCT07387380

Symptom relief Sponsor: Lucie Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called KIRA that is designed to suction blood from the uterus during cesarean deliveries and collect it in a clear container so the surgical team can see and measure how much blood is lost. Ten adult women undergoing c-sections participated. The main goal was to check the device's safety and how easy it is to use.

What this could mean

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

Active substance
KIRA uterine drain device
What this could lead to
If successful, this device could help surgical teams better monitor and manage blood loss during cesarean deliveries, potentially improving safety.
What could go wrong
This is a very early, small study with only 10 participants. The device may not work as intended or could cause unexpected side effects. More research is needed.

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

10 people

The number who actually took part.

Started

Jan 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult, sex female at birth, age 18 years or older at the time of consent. * Able to understand and provide informed consent to participate in the study. * Undergoing c-section Exclusion Criteria: * Ongoing intrauterine pregnancy * Untreated uterine rupture * Unresolved uterine inversion * Known uterine, cervical, or vaginal anomaly that would prohibit device placement. * Placenta abnormality including a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal. * Diagnosis of coagulopathy * Current cervical cancer * Current purulent infection of vagina, cervix or uterus. * History of allergy to device materials (thermoplastic elastomers (TPE), acrylonitirile butadiene styrene plastic (ABS), cyanoacrylate) * Lack of study consent

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As listed by the trial registrant

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

Cesarean delivery procedures

Contacts and locations

Locations

  • Ohio State University

    Columbus, Ohio, 43210, United States

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