Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07387380

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

Led by Lucie Medical Inc · Updated on 2026-02-04

10

Participants Needed

1

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 cesarean section (c-section)
Not Eligible

You will not qualify if you...

  • Ongoing intrauterine pregnancy
  • Untreated uterine rupture
  • Unresolved uterine inversion
  • Known uterine, cervical, or vaginal anomaly that would prohibit device placement
  • Placenta abnormality including known placenta accreta, retained placenta with risk factors for placenta accreta, or 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, acrylonitrile butadiene styrene plastic, cyanoacrylate)
  • Lack of study consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

R

Rachel Acuna-Narvaez, JD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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