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Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

NCT02883673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2022-08-22

Study results available
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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.

Conditions

  • Postpartum Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Alydia Health

    lead INDUSTRY

Principal Investigators

  • Mary D'Alton, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-17
Primary Completion
2020-01-26
Completion
2020-03-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883673 on ClinicalTrials.gov