NCT06166771

Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ResQ Medical Ltd · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours 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. The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Detailed description

A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the 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 SAEs 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 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.

Conditions

• Postpartum Hemorrhage \(PPH\)
• Postpartum Hemorrhage \(Primary\)
• PPH

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-12-12
• Last updated: 2024-10-23

Locations

1 site across 1 country: Kenya