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

Lucie Medical Inc10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cesarean Delivery Procedures

Interventions

Uterine drain for use in cesarean sectionDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Measured at study exit, approximately 3 days

Secondary Outcomes

Ease of use questionnaire

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

Time frame: Within 2 weeks of study completion

Cumulative blood loss

Time frame: Measured through 24 hours from time of delivery

Data from ClinicalTrials.gov

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