Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Rate of related SAEs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult Female, 18 years of age or older at time of consent.
- •Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
- •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.
- •Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Exclusion Criteria
- •Subjects who do not provide informed consent to participate in the clinical investigation.
- •Subjects who deliver at a uterus size < 34 weeks.
- •Subjects who have lost > 1000 ml of blood for vaginal birth and > 2000 ml for caesarian delivery.
- •Subjects who have abnormal PT, PTT and INR.
- •Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
- •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.
- •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.
- •Known uterine rupture
- •Unresolved uterine inversion.
Outcomes
Primary Outcomes
Rate of related SAEs
Time Frame: 6 weeks
Rate of device related SAEs up to six weeks following device treatment
Rate of Damage to Cervix, Uterus or Vagina
Time Frame: Procedure
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Rate of Occurrence of Uterine Inversion or Folding
Time Frame: Procedure
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
Secondary Outcomes
- Rate of Uterine Contraction(Procedure)
- Time to Visible Reduction in Blood Flow(Procedure)
- User Feedback on Connection to Vacuum(Procedure)
- User Feedback on Placement of Alma(Procedure)