Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033170
• Other study ID #: PMCF_PPH 01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Medtrade
• Contact: June Gladman
• Phone: +44 (0)1270 500 019
• Email: June.Gladman[@]medtrade.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: October 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtrade	Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).	The rate of patients in whom bleeding is controlled successfully.	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.