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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02883673
Other study ID # CIP-01 v2.6
Secondary ID PPH-02
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2017
Est. completion date March 25, 2020

Study information

Verified date August 2022
Source Alydia Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.


Description:

This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Jada System
It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.

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Sponsors (1)

Lead Sponsor Collaborator
Alydia Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Rate of Participants With Cessation of Uterine Hemorrhaging Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use 24 hrs
Primary Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events Experienced by Participants Incidence (i.e., rate or number of participants), severity and seriousness of device-related Adverse Events experienced by participants will be documented during the course of the study. 6 weeks
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