Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-10-31

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).

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insertion of CELOX™ PPH trans-vaginally for bleeding control

There is only one group.

Group Type EXPERIMENTAL

CELOX™ PPH

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes