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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
KOKO Medical Inc.
Study ID
NCT06452355
Status
Recruiting
Apply to this trial

Conditions

  • Hemorrhage, Postpartum
  • Immediate Postpartum Hemorrhage
  • Postpartum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KOKO Device — 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.

Study Details

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.

Key Dates

Start date
Aug 29, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    The KOKO device will be administered to participants who are diagnosed with abnormal postpartum uterine bleeding or hemorrhage.

Primary Outcome Measure

Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging [ Time Frame: 24 Hrs ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233
Deepti Sharma, MD (PRINCIPAL_INVESTIGATOR)
Christiana CareNewarkDelaware19718
Carrie Kitto
[email protected]
Matthew Hoffman, FACOG MD MPH (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Caroline Torres
[email protected]
917-686-0653
Michael Paidas, MD (PRINCIPAL_INVESTIGATOR)
Gelila Goba, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of Medicine, Dept. of OBGYNIndianapolisIndiana46202
Tamra Bryant, MD
[email protected]
Christina Scifres, MD (PRINCIPAL_INVESTIGATOR)
Emily Cassell, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536-
Ochsner BaptistNew OrleansLouisiana70115-
LSU Heath Sciences Center - ShreveportShreveportLouisiana71103
Jessica Paul
[email protected]
318-675-7066
Caitlin Busada, MD (PRINCIPAL_INVESTIGATOR)
Sunrise Hospital and Medical CenterLas VegasNevada89109
Michelle Crawford
[email protected]
702-382-3200
Brian Iriye, MD (PRINCIPAL_INVESTIGATOR)
New York-Presbyterian Medical Group QueensFlushingNew York11355
Tina Dardac
[email protected]
718-670-1462
Daniel Skupski, MD (PRINCIPAL_INVESTIGATOR)
New York-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC)New YorkNew York10032
Casandra Almonte
[email protected]
Dena Goffman, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Kristin Weaver
[email protected]
919-681-0308
Jerome Federspiel, MD (PRINCIPAL_INVESTIGATOR)
MetroHealthClevelandOhio44109
Brittany DeSantis
[email protected]
Kelly Gibson, MD (PRINCIPAL_INVESTIGATOR)
The Cleveland ClinicClevelandOhio44111
Luann Polito
[email protected]
Maeve Hopkins, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210-
Medical University of South CarolinaCharlestonSouth Carolina29425
Jesslyn Payne
[email protected]
843-876-1200
Eliza McElwee, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Sarah Tounsi, MD
[email protected]
832-822-2229
Catherine Epps, MD (PRINCIPAL_INVESTIGATOR)
UT Health HoustonHoustonTexas77030
Sunbola Ashimi, PhD
[email protected]
713-500-6484
Megan Shepherd, MD (PRINCIPAL_INVESTIGATOR)
UT Health San AntonioSan AntonioTexas78229
Sally Kabro
[email protected]
708-560-1402
Patrick Ramsey, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Emily Powers
[email protected]
Marcela Smid, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALChristiana Care· Newark, DEUniversity of Miami· Miami, FLIndiana University School of Medicine, Dept. of OBGYN· Indianapolis, INUniversity of Kentucky· Lexington, KYOchsner Baptist· New Orleans, LA

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