Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage ("Alma system")

December 11, 2023 updated by: ResQ Medical Ltd

Prospective, non-randomized, feasibility pilot study Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur immediately after vaginal birth or cesarean section.

In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.

Prospective, non-randomized, feasibility pilot study The purpose of this study, clinical trial, is to obtain information on the safety and effectiveness of the investigational new medical device - Alma System,.

Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.

The main questions are:

  1. Rate of device related SAE up to six weeks following device treatment.
  2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
  3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure.

main tasks for participants:

  • sign the informed Consent form and enrolment
  • In case of PPH, treatment with Alma
  • Participate in 2 visit followup After the treatment- 1st upon discharge and 2nd after 8 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kenya
      • Nairobi, Kenya
        • UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alfred Osoti, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult Female, 18 years of age or older at time of consent.
  2. Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
  3. Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum less than or equal to 500 ml and according to the Investigators judgment, require an intervention.
  4. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Exclusion Criteria:

  1. Subjects who do not provide informed consent to participate in the clinical investigation.
  2. Subjects who deliver at a uterus size less than 34 weeks.
  3. Subjects who have lost greater than 1000 ml of blood.
  4. Subjects who have abnormal PT, PTT and INR
  5. Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.

  6. 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.

  7. Placental 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.
  8. Known uterine rupture.
  9. Unresolved uterine inversion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Woman who developed PPH after vaginal birth and first line therapies have been attempted and faile
Group which Alma treatment was applied
Device: Alma system
Subjects diagnosed with 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.
Other Names:
  • Vacuum induced heamorrhage control
  • Obstetric-gynecologic specialized manual instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy, rate of participants with cessation of uterine hemorrhaging
Time Frame: 8 weeks
Managing postpartum hemorrhage refers to preventing the need for any non-surgical, secondary, or surgical intervention to control uterine bleeding subsequent to employing the Alma System as directed in the Instructions for Use.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Incidence, severity, and seriousness of device-related adverse events experienced by participants, assessing safety.
Time Frame: 8 weeks
The study will document the occurrence (frequency or number of participants), severity, and seriousness of device-related Adverse Events experienced by participants throughout the duration of the research.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResQ Medical Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ResqMedical 1
  • ResQ Medical IL # 516181633 (Other Identifier: ResQ Medical Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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