Clinical Trials Logo
  1. Home
  2. Immediate Postpartum Hemorrhage
  3. NCT06452355

Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage — SERENE  

Postpartum Hemorrhage Clinical Trial

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")

Clinical Trial 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.

Clinical Trial Description

This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06452355
Study type Interventional
Source KOKO Medical Inc.
Contact Cathy Unruh
Phone 610-215-2011
Email cathyu@kokomed.com
Status Not yet recruiting
Phase N/A
Start date June 30, 2024
Completion date July 30, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT03434444 - In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol N/A
Terminated NCT01980173 - Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care N/A
Not yet recruiting NCT06033170 - Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage N/A
Completed NCT02163616 - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study Phase 3
Not yet recruiting NCT02319707 - Management of the Third Stage of Labor Phase 3
Recruiting NCT01600612 - Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial N/A
Completed NCT02079558 - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section Phase 2
Withdrawn NCT01108302 - Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India N/A
Completed NCT00097123 - RCT of Misoprostol for Postpartum Hemorrhage in India N/A
Completed NCT02883673 - Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage N/A
Completed NCT02542813 - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers Phase 1
Completed NCT04201665 - EMG for Uterotonic Efficiency Estimation N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Not yet recruiting NCT05501106 - Reducing Postpartum Hemorrhage After Vaginal Delivery N/A
Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4