Postpartum HemorrhageNCT06033170
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
A study testing CELOX™ PPH in people with Postpartum Hemorrhage, run by Medtrade.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- CELOX™ PPH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- Being tested
- CELOX™ PPH
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELOX™ PPHDevice
Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.
| Study group | Role | What they receive |
|---|---|---|
| Insertion of CELOX™ PPH trans-vaginally for bleeding control | Experimental | There is only one group. Receives: Device: CELOX™ PPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
The rate of patients in whom bleeding is controlled successfully.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtrade
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Anna Maria Dückelmann, MD, Principal investigator, Charite University, Berlin, GermanyNIK Abdullah, MD, Principal investigator, Hospital Raja Perempuan Zainab II - Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033170
- Sponsor's protocol ID
- PMCF_PPH 01
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06033170
- Acronym / sponsor ID
- PMCF_PPH 01
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- MedtradeIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insertion of CELOX™ PPH trans-vaginally for bleeding control | Experimental | Device: CELOX™ PPHThere is only one group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELOX™ PPHCelox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted. | Device | Insertion of CELOX™ PPH trans-vaginally for bleeding control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Maria Dückelmann, MD principal investigator
Charite University, Berlin, Germany
NIK Abdullah, MD principal investigator
Hospital Raja Perempuan Zainab II - Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing CELOX™ PPH in people with Postpartum Hemorrhage, run by Medtrade.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact June Gladman (+44 (0)1270 500 019, June.Gladman@medtrade.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.