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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: Recruiting NA study of Postpartum Hemorrhage and Immediate Postpartum Hemorrhage, sponsored by KOKO Medical.
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 776-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (91% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second line or surgical intervention to control abnormal postpartum uterine bleeding or hemorrhage after the use of the KOKO device.
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 |
What NCT06452355 shows while recruiting
NCT06452355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 776-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (91% lower).
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 lists 19 locations in 13 states (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.
Learn More About Clinical Trials
Similar trials for Postpartum Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06452355's enrollment target sits among peer trials
72 13th of 19 higher than 7 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
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