Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Sponsor

Medtrade (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033170

Collaborator

Charite University, Berlin, Germany (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Device: CELOX™ PPH	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, Single-Arm Confirmatory Clinical Investigation to Demonstrate the Effectiveness, Performance, and Safety of the Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insertion of CELOX™ PPH trans-vaginally for bleeding control There is only one group.	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.

Arm

Intervention/Treatment

Experimental: Insertion of CELOX™ PPH trans-vaginally for bleeding control

There is only one group.

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.

Outcome Measures

Primary Outcome Measures

Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH). [Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox PPH. It is expected that within 2-5 minutes of application, the bleeding will be controlled.]
The rate of patients in whom bleeding is controlled successfully.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
Female Adult subjects (>18 years of age).
Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery.
Subjects with coagulation disorders can be included
Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section.
Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use.
Subjects with PPH of cervical or vaginal origin.

Exclusion Criteria:

Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE).

Pregnancy or incomplete multiple pregnancy
Unresolved uterine inversion.
Current cervical cancer.
Current purulent infection of the vagina, cervix, uterus.
Planned c-section with closed cervix.
Patients requiring trans-abdominal insertion of Celox™ PPH.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medtrade
Charite University, Berlin, Germany

Investigators

Principal Investigator: Anna Maria Dückelmann, MD, Charite University, Berlin, Germany
Principal Investigator: NIK Abdullah, MD, Hospital Raja Perempuan Zainab II - Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtrade

ClinicalTrials.gov Identifier:

NCT06033170

Other Study ID Numbers:

PMCF_PPH 01

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postpartum Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Sep 13, 2023