THE CELOX™ PPH STUDY

1. Background
Registration Number	INA-R761M7K
Date of registry approval	05-12-2024
Registration Date	03-12-2024
Secondary identifiers	Yes
Name of issuing authority (for example protocol number, other registries, etc)	Protocol Number
Secondary identifier number	PMCF_PPH 01
Scientific study 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
Public (popular study title)	THE CELOX™ PPH STUDY
2. Sponsor and Funding
Primary Sponsor	Medtrade Products Limited
Source(s) of monetary or material support	Medtrade Products Limited, Electra House, Crewe Business Park, Crewe, Cheshire, England, CW1 6GL T: +44 (0)1270 500 019 E: info@medtrade.co.uk
Other partners	NA
3. Contact details
Principal Investigator
Principal investigator	Dr. dr. Muhammad Nurhadi Rahman, Sp.OG, Subsp Urogin-RE
City	Yogyakarta
Country	Indonesia
Principal investigator's affiliation	Clinical Epidemiology and Biostatistic Unit (CE&BU) FK-KMK UGM
Principal Investigator's email address	nurhadi.rahman@ugm.ac.id
Public Queries
Contact person name for public queries	Sue McLoughlin
Address for public queries	Medtrade Products Limited, Electra House, Crewe Business Park, Crewe, Cheshire, England, CW1 6GL T: +44 (0)1270 500 019 E: info@medtrade.co.uk
City	Crewe, Cheshire
Country	England
ZIP	-
Affiliation for public queries	Regulatory Affairs Director - Medtrade Products Limited
Email address for public queries	Sue.McLoughlin@medtrade.co.uk
Phone number for public queries	+44 (0)1270 500 019
Scientific Queries
Name of Contact for scientific queries	Dr. dr. Muhammad Nurhadi Rahman, Sp.OG, Subsp Urogin-RE
Address for scientific queries	Gedung Litbang,Fakultas Kedokteran Kesehatan Masyarakat dan Keperawatan (FK-KMK) Universitas Gadjah Mada Lantai 1. Jl. Medika, Senolowo, Mlati, Sleman, Yogyakarta, Indonesia
City	Yogyakarta
Country	Indonesia
ZIP	55281
Affiliation of scientific queries contact	Principal Investigator
Email address for scientific queries	pusatcebu.fkkmk@ugm.ac.id
4. IRB & Regulatory
Ethical Approval number	KE/FK/1268/EC/2024
Name of Ethics committee	Medical and Health Research Ethics Committee (MHREC), Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada Dr.Sardjito General Hospital
Date of Ethic approval	04-09-2024
Contact details of Ethic Committee (phone, email, and office)	Medical and Health Research Ethics Committee (MHREC), Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada Dr.Sardjito General Hospital Gedung Pusat UGM- Lantai 3 Sayap Selatan,Bulaksumur, Yogyakarta, Indonesia 55281 Telp/Fax.: (+62 274) 520669 Email: komisietik@ugm.ac.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	FH. 03.03/E/2002/2024
5. Status
Countries of recruitment	Germany, Indonesia
Study sites in Indonesia	1. RSU Sakina Idaman Address: Jl. Nyi Tjondrolukito Jl. Blunyah Gede No.60, Kutu Dukuh, Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55284 2. RSKIA Sadewa Address: Jl. Babarsari Blok TB 16 No.13B, Tambak Bayan, Caturtunggal, Kec. Depok, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281 3. RSUD Muntilan Address: Jl. Kartini No.13, Balemulyo, Muntilan, Kec. Muntilan, Kabupaten Magelang, Jawa Tengah 56411
Recruitment status	Recruit
Date of first enrollment	17-12-2023
Targeted Sample size	00096 -
Number of enrolled participants	37
Date of study completion (last participant, last visit)
6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Uterine Postpartum Hemorrhage (PPH)
Purpose of the study	Treatment
Study type	Interventional
Interventional Study category	Clinical trial
Study phase	Phase 4
Method of allocation	Not Applicable (single arm study)
Description of the allocation concealment mechanism and sequence generation
Masking	No (open)
Study intervention (study arm)	CELOX™ PPH Gauze insertion
Control intervention (control arm)	No treatment / No control arm
Intervention assignment	Single arm
7. Eligibility Criteria
Gender inclusion criteria	Female
Minimum age	18
Maximum age	Not defined/No maximum age
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 or c-section 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 (Note: From prior use we know that the cervical and vaginal PPH indications are less frequent, however Celox™ PPH has been used successfully in these indications. Therefore, to generate observational data in these indications, these subjects may be included in this clinical investigation, but their data will be analysed outside the formal sample size as observational only)
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.
8. Study Outcome
Primary Outcome
Name of primary outcome	Effectiveness: To demonstrate effectiveness of the Celox™ PPH in controlling uterine bleeding for postpartum hemorrhage (PPH).
Metric/method of measurement	Clinical Effectiveness: The rate of patients in whom bleeding is controlled successfully. Note: Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox™ PPH
Timepoint(s) of measurement	Within 24 hours after the CELOX™ PPH Gauze insertion
Secondary outcome 1
Name of secondary outcome 1 (SO1)	SAFETY: To demonstrate the safety of the use of Celox™ PPH by observation of any device related adverse reaction.
Metric/method of measurement (SO1)	Percentage of adverse device effects with specific focus on: i. The rate of infection ii. Damage to the uterine wall iii. Allergic reaction iv. Rate of non-surgical or surgical interventions other than CELOX™ PPH for treatment of uterine atony postpartum haemorrhage after application of CELOX™ PPH v. Occurrence of any non-device/procedure related events from screening start to last follow up. vi. Occurrence of any device deficiencies. Long term safety follow-up: i. Observation of return of normal endometrial thickness as demonstrated by ultrasound scan (USS) examination at 6 weeks after treatment. ii. Observation of occurrence of new pregnancy within 12 months after treatment and subsequent observation of healthy pregnancy/birth.
Timepoint(s) of measurement (SO1)	Within 24 hours after the CELOX™ PPH Gauze insertion and during 6weeks and 12 month follow up.
Secondary outcome 2
Name of secondary outcome 2 (SO2)	Clinical Performance/effectiveness i. Volume of blood loss after application ii. Time to haemostasis iii. Ease of application and removal iv. Duration of application of CELOX™ PPH
Metric/method of measurement (SO2)	Clinical Performance/effectiveness i. Volume of blood loss after application ii. Time to haemostasis measured in minutes from start of application of CELOX™ PPH to successful haemostasis iii. Ease of application and retrieval iv. Duration of application of CELOX™ PPH Other observation endpoints: i. Volume of blood transfusions (units of blood) and other blood derivatives. ii. Time spent in care units during CELOX™ PPH treatment.
Timepoint(s) of measurement (SO2)	Within 24 hours after the CELOX™ PPH Gauze insertion and during 6weeks and 12 month follow up.
9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic
Adverse events
Outcome measures
10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	Undecided
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations