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

Lucie Medical Inc

Status: Enrolling

Conditions: Cesarean Delivery Procedures

Treatments: Device: Uterine drain for use in cesarean section

Study type: Interventional

Funder types: Industry

Identifiers

NCT07387380

CP-01

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Interventional

Experimental group

Description:

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.

Treatment:

Device: Uterine drain for use in cesarean section