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EVE TRIAL , ALMA SYSTAM

NCT06646653 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-30

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • ResQ Medical Ltd

    lead OTHER

Principal Investigators

  • Scott Chudnoff, MD · Maimonides Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-11
Primary Completion
2027-01-31
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646653 on ClinicalTrials.gov