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RUBY Post-Market Registry on the Jada® System

NCT04995887 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 809

Last updated 2022-08-22

No results posted yet for this study

Summary

The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

Jada® System

The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. 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

  • Dena Goffman, MD · Columbia University

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-03-31
Completion
2022-04-30
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 NCT04995887 on ClinicalTrials.gov