KIRA Uterine Drain Device Evaluation- First-In- Human Study
KIRA Uterine Drain Device Evaluation - First-In- Human Study
Lucie Medical Inc
10 participants
Jan 6, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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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Interventions
The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07387380