Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Medtrade

Status: Not yet enrolling

Conditions: Postpartum Hemorrhage

Treatments: Device: CELOX™ PPH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06033170

PMCF_PPH 01

Details and patient eligibility

About

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).

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Insertion of CELOX™ PPH trans-vaginally for bleeding control

Experimental group

Description:

There is only one group.

Treatment:

Device: CELOX™ PPH