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

NARecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 29, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

August 30, 2026

Conditions
Postpartum HemorrhageImmediate Postpartum HemorrhageHemorrhage, Postpartum
Interventions
DEVICE

KOKO Device

The intrauterine drain is extended into the uterus, where low pressure vacuum is applied to the uterus through the fabric intrauterine drain. The KOKO™ device utilizes this vacuum to remove excess blood and compress the uterus reducing further blood loss.

Trial Locations (14)

10032

RECRUITING

New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC), New York

19718

RECRUITING

Christiana Care, Newark

29425

NOT_YET_RECRUITING

Medical University of South Carolina, Charleston

33136

RECRUITING

University of Miami, Miami

35233

RECRUITING

University of Alabama, Birmingham

43210

RECRUITING

The Ohio State University, Columbus

44109

RECRUITING

MetroHealth, Cleveland

44111

RECRUITING

The Cleveland Clinic, Cleveland

46202

RECRUITING

Indiana University School of Medicine, Dept. of OBGYN, Indianapolis

70115

WITHDRAWN

Ochsner Baptist, New Orleans

71103

RECRUITING

LSU Heath Sciences Center - Shreveport, Shreveport

77030

NOT_YET_RECRUITING

Baylor College of Medicine, Houston

84132

RECRUITING

University of Utah, Salt Lake City

89109

NOT_YET_RECRUITING

Sunrise Hospital and Medical Center, Las Vegas

All Listed Sponsors
lead

KOKO Medical Inc.

INDUSTRY