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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insertion of CELOX™ PPH trans-vaginally for bleeding control | Experimental | There is only one group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELOX™ PPH | Device | Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted. |
| 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. |
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Inclusion Criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| June Gladman | Contact | +44 (0)1270 500 019 | June.Gladman@medtrade.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Anna Maria DĂĽckelmann, MD | Charite University, Berlin, Germany | Principal Investigator |
| NIK Abdullah, MD | Hospital Raja Perempuan Zainab II - Malaysia | Principal Investigator |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |