Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Public ClinicalTrials.gov record NCT06452355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")
Study identification
- NCT ID
- NCT06452355
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- KOKO Medical Inc.
- Industry
- Enrollment
- 72 participants
Conditions and interventions
Interventions
- KOKO Device Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2024
- Primary completion
- Jun 29, 2026
- Completion
- Aug 31, 2026
- Last update posted
- May 12, 2026
2024 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | Recruiting |
| Christiana Care | Newark | Delaware | 19718 | Recruiting |
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Indiana University School of Medicine, Dept. of OBGYN | Indianapolis | Indiana | 46202 | Recruiting |
| University of Kentucky | Lexington | Kentucky | 40536 | Recruiting |
| Ochsner Baptist | New Orleans | Louisiana | 70115 | Withdrawn |
| LSU Heath Sciences Center - Shreveport | Shreveport | Louisiana | 71103 | Recruiting |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | Recruiting |
| New York-Presbyterian Medical Group Queens | Flushing | New York | 11355 | Recruiting |
| New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC) | New York | New York | 10032 | Recruiting |
| Duke University | Durham | North Carolina | 27705 | Recruiting |
| MetroHealth | Cleveland | Ohio | 44109 | Recruiting |
| The Cleveland Clinic | Cleveland | Ohio | 44111 | Recruiting |
| The Ohio State University | Columbus | Ohio | 43210 | Active, not recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| UT Health Houston | Houston | Texas | 77030 | Recruiting |
| UT Health San Antonio | San Antonio | Texas | 78229 | Not yet recruiting |
| University of Utah | Salt Lake City | Utah | 84132 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06452355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2026 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06452355 live on ClinicalTrials.gov.