Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452355
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
Sponsor:
KOKO Medical Inc
Organization:
KOKO Medical Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERENE
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None