MedTrace Logo

Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

NCT06033170 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-09-13

No results posted yet for this study

Summary

This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

CELOX™ PPH

Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Medtrade

    lead INDUSTRY

Principal Investigators

  • Anna Maria Dückelmann, MD · Charite University, Berlin, Germany

  • NIK Abdullah, MD · Hospital Raja Perempuan Zainab II - Malaysia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-09-30
Completion
2025-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06033170 on ClinicalTrials.gov