THE CELOX™ PPH STUDY
Tahapan Penelitian : Recruit
Sponsor:
Medtrade Products Limited
Mitra Pelaksana:
NA
No Registry
INA-R761M7K
Tanggal Input Registry : 03-12-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 17-12-2023 |
| Outcome Primer | Effectiveness: To demonstrate effectiveness of the Celox™ PPH in controlling uterine bleeding for postpartum hemorrhage (PPH). |
| Outcome Skunder | SAFETY: To demonstrate the safety of the use of Celox™ PPH by observation of any device related adverse reaction. |
| Descriptive Information | |
| Judul Penelitian Popular | THE CELOX™ PPH STUDY |
| Judul Penelitian Ilmiah | 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 |
| Jenis Penelitian | Interventional |
| Intervensi | CELOX™ PPH Gauze insertion |
| Jumlah Subyek Penelitian | 96 |
| Recruitment Information | |
| Eligibility Criteria | 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. |
| Administrative Information | |
| Nomor Persetujuan Etik | KE/FK/1268/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PMCF_PPH 01 |
| Contact Person | Sue McLoughlin |