EVE TRIAL , ALMA SYSTAM

NCT06646653 | Recruiting Phase 3 FDA Device

• 1 other identifier: CD-01-001-PR (pivotal)
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

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

Keywords

Alma System; postpartum hemorrhage; pph

Outcome Measures

Primary Outcomes (2)

• Incidence of safety events

  Incidence, severity and seriousness of device-related Adverse Events (AEs).

  6 weeks

• PPH control

  Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Alma System per the Instructions for Use.

  Procedure

Secondary Outcomes (4)

• Hemorrhage control

  minutes to hours

• Surgical Intervention

  minutes to hours

• Non Surgical intervention

  minutes to hours

• Blood product transfusion

  hours to days

Study Arms (1)

Participant group

EXPERIMENTAL

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

Device: Alma System

Interventions

Alma System DEVICE

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.

Also known as: Obstetric-gynecologic specialized manual instrument, Vacuum induced heamorrhage control

Participant group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
• Delivery at a gestational age \< 34 weeks.
• For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma.
• PPH that the investigator determines to require more aggressive treatment, including any of the following:
• hysterectomy;
• b-lynch suture;
• uterine artery embolization or ligation;
• hypogastric ligation.
• Known uterine anomaly.
• Ongoing intrauterine pregnancy.
• Placenta abnormality including any of the following:
• known placenta accreta;
• retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);
• retained placenta without easy manual removal.
• Known uterine rupture.

Sponsors & Collaborators

• ResQ Medical Ltd: lead

Study Sites (2)

Maimonides Medical Center | Brooklyn, New York Hospital

Brooklyn, New York, 11219, United States

NOT YET RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Scott Chudnoff, MD

  Maimonides Medical Center

  STUDY CHAIR

Central Study Contacts

Yael Corcos, RN

CONTACT

972-548106010; yael@resq-med.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: January 11, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1); IL (1)