Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage

NCT ID: NCT06646653

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-14
• Study Completion Date: 2025-04-30

Brief Summary

Feasibility clinical study of the Alma System in treating primary postpartum hemorrhage (PPH).

Detailed Description

10 subjects, first in woman trial with ethics committee oversight. Women who experienced postpartum hemorrhage will be treated with the Alma System, which aims to rapidly reduce or stop the bleeding by targeting the primary cause: uterine atony.

The primary objective is to verify the safety of the Alma System in humans by: 1. Ensuring the absence of serious adverse events (SAEs) related to the use of the Alma System during and after the procedure. 2. Evaluating any observable damage to the uterus, cervix, or vagina due to the use of the Alma System. 3. Evaluating the occurrence of uterine inversion or folding during the use of the Alma System.

The secondary objectives include evaluating: 1. The ability to easily place the Alma System trans-vaginally. 2. The ability to connect the Alma System to a vacuum source and maintain the desired negative pressure. 3. The ability of the Alma System to contract the uterus to a level that reduces or stops blood loss and avoids further non-surgical and surgical intervention. 4. The time from insertion and start of negative pressure to a visible reduction in blood loss.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant group

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

Group Type: EXPERIMENTAL

Alma System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Obstetric-gynecologic specialized manual instrument; Vacuum induced heamorrhage control

Eligibility Criteria

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 placenta with failure to obtain contraction and/or Subjects who have lost blood post-vaginal delivery > = 500 ml and lost blood post-cesarian delivery > = 1000 ml and according to the Investigator's 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 < 34 weeks.

3. Subjects who have lost > 1000 ml of blood for vaginal birth and > 2000 ml for caesarian delivery.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ResQ Medical Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Clinical Hospital of Mostar

Mostar, , Bosnia and Herzegovina

Site Status: RECRUITING

Countries

Bosnia and Herzegovina

Central Contacts

Vajdana Tomic, Prof.

Role: CONTACT

Tomicvajdana5@gmail.com

+387-637-90012

Facility Contacts

Vajdana Tomic, Prof.

Role: primary

Tomicvajdana5@gmail.com

387-637-90012

Vajdana Tomic, Prof.

Role: backup

Other Identifiers

CD-01-002-PR

Identifier Type: -

Identifier Source: org_study_id