Cesarean Delivery ProceduresRANINCT07387380
KIRA Uterine Drain Device Evaluation- First-In- Human Study
A study testing Uterine drain for use in cesarean section in people with Cesarean Delivery Procedures, run by Lucie Medical Inc at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery Procedures
- What is being tested?
- Uterine drain for use in cesarean section
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: KIRA Uterine Drain Device Evaluation - First-In- Human Study
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
- Being tested
- Uterine drain for use in cesarean section
- Keywords
- cesarean delivery, surgical drain, blood loss measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine drain for use in cesarean sectionDevice
The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Uterine drain for use in cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and seriousness of device related Adverse Events (ADE's)
Measured: Measured at study exit, approximately 3 days
Secondary outcomes (2)
Ease of use questionnaire
Likert type scale with higher scores indicating agreement with the statement.
Measured: Within 2 weeks of study completion
Cumulative blood loss
Measured: Measured through 24 hours from time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start6 Jan 2026
- Primary completion5 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucie Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387380
- Sponsor's protocol ID
- CP-01
- Acronym
- RANI
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a feasibility study for a commercial product.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIRA Uterine Drain Device Evaluation - First-In- Human Study
- ClinicalTrials.gov ID
- NCT07387380
- Acronym / sponsor ID
- RANI / CP-01
- Conditions
- Cesarean Delivery Procedures
- Keywords
- cesarean delivery, surgical drain, blood loss measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lucie Medical IncIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Uterine drain for use in cesarean sectionAll participants will be assigned to the interventional arm, in which the uterine drain is used to evaluate the blood loss immediately following cesarean delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine drain for use in cesarean sectionThe intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery. | Device | Interventional |
Primary outcome
Incidence, severity and seriousness of device related Adverse Events (ADE's)
Time frame: Measured at study exit, approximately 3 days
2 secondary outcomes
Ease of use questionnaire
Time frame: Within 2 weeks of study completion
Cumulative blood loss
Time frame: Measured through 24 hours from time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. This is a feasibility study for a commercial product.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine drain for use in cesarean section in people with Cesarean Delivery Procedures, run by Lucie Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and seriousness of device related Adverse Events (ADE's) (time frame: Measured at study exit, approximately 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.