Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

NCT06033170 | Unknown

• 1 other identifier: PMCF_PPH 01
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Insertion of CELOX™ PPH trans-vaginally for bleeding control

EXPERIMENTAL

There is only one group.

Device: CELOX™ PPH

Interventions

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.

Insertion of CELOX™ PPH trans-vaginally for bleeding control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtrade: lead
• Charite University, Berlin, Germany: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Maria Dückelmann, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• NIK Abdullah, MD

  Hospital Raja Perempuan Zainab II - Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June Gladman

CONTACT

+44 (0)1270 500 019; June.Gladman@medtrade.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share