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

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

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.

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