KIRA Uterine Drain Device Evaluation - First-In- Human Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence, severity and seriousness of device related Adverse Events (ADE's)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Uterine drain for use in cesarean section (Device)
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(Within 2 weeks of study completion)
- Cumulative blood loss(Measured through 24 hours from time of delivery)