KIRA Uterine Drain Device Evaluation - First-In- Human Study
Lucie Medical Inc
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 placent…
Interventions
- DeviceUterine drain for use in cesarean section
The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.
Location
- Ohio State UniversityColumbus, Ohio