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

NCT07387380 | Completed FDA Device

• 1 other identifier: CP-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cesarean Delivery Procedures

Keywords

cesarean delivery; surgical drain; blood loss measurement

Outcome Measures

Primary Outcomes (1)

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

  Measured at study exit, approximately 3 days

Secondary Outcomes (2)

• Ease of use questionnaire

  Within 2 weeks of study completion

• Cumulative blood loss

  Measured through 24 hours from time of delivery

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucie Medical Inc: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 4, 2026
• Study Start: January 6, 2026
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)