NCT04364386

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Alydia Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Post Partum Hemorrhage

Interventions

Type	Name	Description
DEVICE	InPress Device	Treatment with InPress Device for Postpartum Hemorrhage

Timeline

• Start date: 2014-07-27
• Primary completion: 2015-02-11
• Completion: 2015-04-01
• First posted: 2020-04-28
• Last updated: 2024-09-19
• Results posted: 2023-05-30

Locations

2 sites across 1 country: Indonesia

Regulatory

• FDA-regulated device study