KIRA Uterine Drain Device Evaluation- First-In- Human Study

Completed · Not applicable

Conditions studied: Cesarean Delivery Procedures

In brief

The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor blood loss during and immediately after cesarean deliveries (c-sections). This study will assess the safety of the device and the device's ability to gently suction blood from the uterus into a clear container where it can be seen and measured by the surgical team.

Key facts

Study ID

NCT07387380

Run by

Lucie Medical Inc

People needed

10

Starts

2026-01-06

Expected to finish

2026-04-05

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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