NCT06033170Not yet recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medtrade
- Enrollment
- 96
- Primary Endpoint
- Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
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