[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ResQ Medical Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100565782","phase-3-eve-trial--alma-systam-100565782",false,"NCT06646653","EVE TRIAL , ALMA SYSTAM","Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage","EVE","1. Adult Female, 18 years of age or older at time of consent.\n2. Able to understand and provide informed consent to participate in the study.\n3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.\n4. EBL, determined when investigator is ready to have the Alma peel pack opened:\n\n   Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL\n5. Failed first-line intervention of uterotonics and uterine massage\u002Fbimanual uterine massage to stop bleeding.\n\nNote: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria\n\n1. EBL \\>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.\n2. Delivery at a gestational age \\\u003C 34 weeks.\n3. For Cesarean-sections birth: Cervix \\\u003C 3 cm dilated before use of Alma.\n4. PPH that the investigator determines to require more aggressive treatment, including any of the following:\n\n   1. hysterectomy;\n   2. b-lynch suture;\n   3. uterine artery embolization or ligation;\n   4. hypogastric ligation.\n5. Known uterine anomaly.\n6. Ongoing intrauterine pregnancy.\n7. Placenta abnormality including any of the following:\n\n   1. known placenta accreta;\n   2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);\n   3. retained placenta without easy manual removal.\n8. Known uterine rupture.\n9. Unresolved uterine inversion.\n10. Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.\n11. Current cervical cancer.\n12. Current purulent infection of vagina, cervix, uterus.\n13. Diagnosis of coagulopathy.","FEMALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment.\n\nWhat you need to know:\n\n* Signing this form does not mean you will have an emergency postpartum bleeding.\n* We will only include you in the study IF abnormal bleeding happens after your birth.\n* If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol.\n* The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding.\n\nTreatment Schedule - Recruitment \\& Consenting\n\n* Screening and enrolment.\n* Treatment of PPH with Alma system.\n* Alma Survey\n* Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital).\n* 6-week postpartum follow-up examination.",[27,28,29],"Postpartum Haemorrhage (PPH)","PPH","Postpartum Hemorrhage (Primary)",[31,32,33],"Alma System","postpartum hemorrhage","pph","RECRUITING","2026-03-25",{"date":37,"type":38},"2026-03-30","ACTUAL",{"date":40,"type":38},"2026-01-11",{"date":42,"type":21},"2027-04",{"name":44,"class":45},"ResQ Medical Ltd","OTHER",2,""]