Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Device: CELOX™ PPH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insertion of CELOX™ PPH trans-vaginally for bleeding control<br>There is only one group. | Device: CELOX™ PPH<br>* Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |