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NCT06452355 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
A NA study of Postpartum Hemorrhage and Immediate Postpartum Hemorrhage, sponsored by KOKO Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 19
- Study locations
NCT06452355 is a NA study of Postpartum Hemorrhage and Immediate Postpartum Hemorrhage that is actively recruiting participants, run by KOKO Medical. The registered enrollment target is 72 participants, below the 198-participant average among 11 other Postpartum Hemorrhage trials with a reported enrollment target (64% lower). The trial reports 19 study locations across 13 states.
The verdict
NCT06452355, a NA study of Postpartum Hemorrhage and Immediate Postpartum Hemorrhage, is actively recruiting participants, sponsored by KOKO Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 19
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
Conditions Studied
Interventions
- DEVICE KOKO Device
Study Locations (19)
Ohio
- MetroHealth - Cleveland
- The Cleveland Clinic - Cleveland
- The Ohio State University - Columbus
Texas
- Baylor College of Medicine - Houston
- UT Health Houston - Houston
- UT Health San Antonio - San Antonio
Louisiana
- Ochsner Baptist - New Orleans
- LSU Heath Sciences Center - Shreveport - Shreveport
New York
- New York-Presbyterian Medical Group Queens - Flushing
- New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC) - New York
Alabama
- University of Alabama - Birmingham
Delaware
- Christiana Care - Newark
Florida
- University of Miami - Miami
Indiana
- Indiana University School of Medicine, Dept. of OBGYN - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2026-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06452355
The ClinicalTrials.gov registry entry for NCT06452355 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 11 other Postpartum Hemorrhage trials with a reported enrollment target (64% lower). The listed sponsor is KOKO Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Postpartum Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which KOKO Device is the first listed.
NCT06452355 reports 19 study locations spanning 13 distinct geographic areas - top geographies include Ohio, Texas, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06452355 about?
NCT06452355 is a clinical study titled "Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage". The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
What is the current status of trial NCT06452355?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2024-08-29. Estimated completion is 2026-08-30.
What conditions does trial NCT06452355 study?
This clinical trial studies the following conditions: Postpartum Hemorrhage, Immediate Postpartum Hemorrhage, Hemorrhage, Postpartum.
What interventions are being tested in trial NCT06452355?
The interventions under investigation include: KOKO Device (DEVICE).
Who is sponsoring clinical trial NCT06452355?
This trial is sponsored by KOKO Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06452355 being conducted?
This trial has 19 study locations across Alabama, Delaware, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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