Skip to main content
OpenTrials
Completed

NCT Number: NCT07387380

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Delivery Procedures

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uterine drain for use in cesarean section

Device

The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.

Primary outcomes

  1. Incidence, severity and seriousness of device related Adverse Events (ADE's)

    Time frame: Measured at study exit, approximately 3 days

Secondary outcomes

  1. Ease of use questionnaire

    Time frame: Within 2 weeks of study completion

    Likert type scale with higher scores indicating agreement with the statement.

  2. Cumulative blood loss

    Time frame: Measured through 24 hours from time of delivery

Sponsors and collaborators

Lead sponsor

Lucie Medical Inc

Industry

Registry information

Official study title

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

Acronym: RANI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.