First-in-human KIRA uterine drain for cesarean deliveries
KIRA Uterine Drain Device Evaluation - First-In- Human Study
This study will test a new KIRA uterine drain in adults having cesarean delivery to gently suction and collect uterine blood so the surgical team can see and measure bleeding during and immediately after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Lucie Medical Inc Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07387380 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, interventional study of the KIRA uterine drain used during cesarean delivery to move blood from the uterus into a clear collection container for real-time measurement. The device is placed intraoperatively and provides gentle suction to capture blood while the surgical team observes and records collected volume. The study focuses on device safety and the device's ability to reliably collect and display blood for measurement, with predefined exclusions for conditions that could complicate placement or safety. Enrollment is at a single academic center with consenting adult patients undergoing cesarean delivery who meet inclusion/exclusion criteria.
Who should consider this trial
Good fit: Adults sex female at birth, age 18 or older, who can consent and are scheduled for cesarean delivery without excluded uterine or placental conditions are ideal candidates.
Not a fit: People with known placenta abnormalities (including placenta accreta), unresolved uterine rupture or inversion, coagulopathy, active genital tract infection, prohibitive uterine or vaginal anomalies, or allergies to device materials are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the device could give surgical teams a clearer, immediate measure of blood loss during cesarean delivery, helping detect and manage hemorrhage sooner.
How similar studies have performed: This is the first-in-human use of this specific KIRA device; while methods to estimate surgical blood loss exist, published human data on comparable uterine-specific drains are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Rachel Acuna-Narvaez, JD
- Email: rachel@adaptiverc.com
- Phone: 650-380-1191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.