Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Not Applicable

Not yet recruiting

• Conditions: Postpartum Hemorrhage
• Interventions: Device: CELOX™ PPH

• Registration Number: NCT06033170
• Lead Sponsor: Medtrade

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insertion of CELOX™ PPH trans-vaginally for bleeding control	CELOX™ PPH	There is only one group.

Primary Outcome Measures

Name	Time	Method
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.