EVE TRIAL , ALMA SYSTAM

ResQ Medical

Status and phase: Enrolling; Phase 3

Conditions: Postpartum Haemorrhage (PPH); Postpartum Hemorrhage (Primary); PPH

Treatments: Device: Alma System

Study type: Interventional

Funder types: Other

Identifiers

NCT06646653

CD-01-001-PR (pivotal)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Adult Female, 18 years of age or older at time of consent.

2. Able to understand and provide informed consent to participate in the study.

3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.

4. EBL, determined when investigator is ready to have the Alma peel pack opened:

   Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL

5. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Note: 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

1. EBL >1500ml, to be determined when investigator is ready to have the Alma peel pack opened.

2. Delivery at a gestational age < 34 weeks.

3. For Cesarean-sections birth: Cervix < 3 cm dilated before use of Alma.

4. PPH that the investigator determines to require more aggressive treatment, including any of the following:

   1. hysterectomy;
   2. b-lynch suture;
   3. uterine artery embolization or ligation;
   4. hypogastric ligation.

5. Known uterine anomaly.

6. Ongoing intrauterine pregnancy.

7. Placenta abnormality including any of the following:

   1. known placenta accreta;
   2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
   3. retained placenta without easy manual removal.

8. Known uterine rupture.

9. Unresolved uterine inversion.

10. 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.

11. Current cervical cancer.

12. Current purulent infection of vagina, cervix, uterus.

13. Diagnosis of coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Participant group

Experimental group

Description:

Woman who developed PPH after vaginal or caesarean delivery and first line interventions have been attempted and failed, and to which the Alma System was applied

Treatment:

Device: Alma System