Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage

Study Overview
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Brief Summary
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Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).

Detailed Description
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10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony. The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device. The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.

Official Title
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Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage

Conditions
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Post Partum Hemorrhage

Intervention / Treatment
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* Device: InPress Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation Female adult subjects (>18 years of age) 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 >= 500 ml and according to the Investigator's judgment, require an intervention. 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 greater than 1000 ml of blood. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InPress<br>Treatment with InPress Device for Postpartum Hemorrhage | Device: InPress Device<br>* Treatment with InPress Device for Postpartum Hemorrhage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Related SAE | Rate of device related SAEs | 6 weeks | 
| Rate of Damage to Cervix, Uterus or Vagina | Rate of any observable damage to cervix, uterus, vagina | Procedure | 
| Rate of Occurrence of Uterine Inversion of Folding | Rate of uterine inversion or folding during procedure | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Feedback on Placement of InPress | Rate of positive user feedback on placement transvaginally | Procedure | 
| User Feedback on Connection to Vacuum | Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure | Procedure | 
| Rate of Uterine Contraction | Rate of Uterine contraction to a level that reduces or stops blood flow | Procedure | 
| Time | Time from insertion to removal of the device | Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Partum Hemorrhage