Feasibility clinical study of the Alma System in treating primary postpartum hemorrhage (PPH).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University Clinical Hospital of Mostar
Mostar, Bosnia and Herzegovina
RECRUITINGRate of related SAEs
Rate of device related SAEs up to six weeks following device treatment
Time frame: 6 weeks
Rate of Damage to Cervix, Uterus or Vagina
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Time frame: Procedure
Rate of Occurrence of Uterine Inversion or Folding
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
Time frame: Procedure
User Feedback on Connection to Vacuum
Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure
Time frame: Procedure
Rate of Uterine Contraction
Rate of uterine contraction to a level that reduces or stops blood flow
Time frame: Procedure
Time to Visible Reduction in Blood Flow
Time from insertion and start of negative pressure to visible reduction in blood flow
Time frame: Procedure
User Feedback on Placement of Alma
Rate of positive user feedback on device placement transvaginally
Time frame: Procedure
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