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

Post Partum Hemorrhage Clinical Trial

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

Clinical Trial Summary

Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04364386
Study type Interventional
Source Alydia Health
Contact
Status Completed
Phase N/A
Start date July 27, 2014
Completion date April 1, 2015
View Details
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