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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ResQ Medical Ltd · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. What you need to know: * Signing this form does not mean you will have an emergency postpartum bleeding. * We will only include you in the study IF abnormal bleeding happens after your birth. * If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol. * The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding. Treatment Schedule - Recruitment \& Consenting * Screening and enrolment. * Treatment of PPH with Alma system. * Alma Survey * Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital). * 6-week postpartum follow-up examination.

Detailed description

Visit 1 - Before Birth (Screening and Enrollment) No study-related procedures will be done until you have reviewed and signed this consent form. The screening visit tests and procedures are done to see if you are eligible to be in the study. This visit could take a few hours to complete. During this visit, we will collect important background information and perform a physical examination. The following tests and procedures will take place: * A purple bracelet will be placed on your wrist to indicate to the clinical team that you have signed this informed consent form. This helps ensure that, in the event of abnormal bleeding, you can be quickly identified as a participant in the study * Demographic information: Including date of birth, race, height, weight, and number of previous childbirths. * Medical History: This includes your past and current health conditions, with particular focus on gynecological issues, prior surgeries, current medications, and any known allergies * Physical examination: including vital signs such as blood pressure and heart rate. * Blood tests: including Complete Blood Count (CBC) and Coagulation Panel. Neither you nor your health care plan/insurance carrier will be billed for the collection of the information that will be used for this study. Visit 2 - Diagnosis and Treatment of Abnormal Bleedong and Post-Partum Hemorrhage (PPH) with the Alma System If you experience abnormal bleeding or postpartum hemorrhage (PPH), your doctor will evaluate all possible causes and follow the hospital's standard treatment protocols. Initial treatment typically includes medications to help the uterus contract and reduce bleeding, as well as manual uterine massage, as recommended by your medical team. If those treatments do not work, your doctor may decide to use the Alma system to help control or reduce the bleeding. Once the Alma system is in place, the medical team will perform an ultrasound to check that the device is placed correctly and remains stable. In addition, the following data will be collected from the treating team: * A questionnaire about how easy the Alma System was to use (Usability Questionnaire). * The amount of time it took to use the Alma System. * Your symptoms and any adverse events (your overall health). * An evaluation of how well the Alma System worked (treatment evaluation). Visit 3 - Post Treatment Follow-up Examination Before you leave the hospital and after removal of the Alma system, your doctor will perform a follow-up exam.s, This will include: * Physical examination, blood tests, vital signs such as blood pressure and heart rate. * Your symptoms and any adverse events (your overall health). Visit 4 - 6-Week Postpartum Follow-up Examination and Study Completion A final study follow-up assessment will take place at your routine 6-week postpartum follow-up check-up. The following assessments will be performed: * Physical Examination * Review of any adverse events Note: If you are unable to return for your routine 6-week postpartum check-up after three documented contact attempts, the study team will follow-up by phone to ask about your overall health since discharge. Any complaints will be investigated.

Conditions

• Postpartum Haemorrhage (PPH)
• PPH
• Postpartum Hemorrhage (Primary)

Interventions

Type	Name	Description
DEVICE	Alma System	Subjects diagnosed with abnormal bleeding or postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding.

Timeline

• Start date: 2026-01-11
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2024-10-17
• Last updated: 2026-03-30

Locations

2 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study