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

Conditions

• Cesarean Delivery Procedures

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jan 6, 2026

Status verified

May 2026

Primary completion

Apr 5, 2026

Completion

Apr 5, 2026

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• 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.

Primary Outcome Measure

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

Locations (1)

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