RecruitingNot Applicable

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

United States72 participantsStarted 2024-08-29

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. hysterectomy;
✕. B-lynch suture;
✕. uterine artery embolization or ligation;
✕. hypogastric ligation.
✕. known placenta accreta;
✕. retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa);
✕. retained placenta without easy manual removal.

What they're measuring

Efficacy: Rate of Participants With Cessation of Abnormal Postpartum Uterine Bleeding or Hemorrhaging

Timeframe: 24 Hrs

Safety: Incidence, Severity and Seriousness of Device-related Adverse Events Experienced by Participants.

Timeframe: 6 weeks

Trial details

NCT IDNCT06452355

SponsorKOKO Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Darra Bigelow

610-215-2010 darra@kokomed.com

View on ClinicalTrials.gov More Postpartum Hemorrhage trials