KIRA Uterine Drain Device Evaluation- First-In- Human Study (RANI)

May 14, 2026 updated by: Lucie Medical Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
All participants will be assigned to the interventional arm, in which the uterine drain is used to evaluate the blood loss immediately following cesarean delivery.
Device: Uterine drain for use in cesarean section
The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, severity and seriousness of device related Adverse Events (ADE's)
Time Frame: Measured at study exit, approximately 3 days
Measured at study exit, approximately 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use questionnaire
Time Frame: Within 2 weeks of study completion
Likert type scale with higher scores indicating agreement with the statement.
Within 2 weeks of study completion
Cumulative blood loss
Time Frame: Measured through 24 hours from time of delivery
Measured through 24 hours from time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucie Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Actual)

April 5, 2026

Study Completion (Actual)

April 5, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a feasibility study for a commercial product.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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