NCT06452355

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: KOKO Medical Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Hemorrhage
• Immediate Postpartum Hemorrhage
• Hemorrhage, Postpartum

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-29
• Primary completion: 2026-06-30
• Completion: 2026-08-30
• First posted: 2024-06-11
• Last updated: 2026-04-14

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study