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

NCT07387380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Lucie Medical Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2026-04-05
Completion
2026-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387380 on ClinicalTrials.gov