Skip to main content
OpenTrials
Completed

NCT Number: NCT04995887

RUBY Post-Market Registry on the Jada® System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Observational

Primary location

Loma Linda University, Loma Linda, California, United States

Loading trial locations.

About this study

The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Use of the Jada System (inserted into the patient and connected to vacuum).

NOTE: There is no Exclusion Criteria in this protocol.

Treatment and study plan

Jada® System

Device

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.

Other names: Vacuum-induced Hemorrhage Control, Obstetric-Gynecologic Specialized Manual Instrument

Primary outcomes

  1. Efficacy: Cessation of PPH

    Time frame: 24 hours

    Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used.

    Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition.

  2. Safety: device-related Adverse Events

    Time frame: 24 hours through time of discharge.

    Rates of procedure- and device-related adverse events.

Secondary outcomes

  1. Rate of non-surgical or surgical procedures other than Jada

    Time frame: 24 hours

    Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used

  2. Transfusion rates

    Time frame: 24 hours through time of discharge.

    Rate of blood transfusions

  3. In-dwelling time of Jada during treatment

    Time frame: 24 hours

    In-dwelling time (i.e., insertion of Jada to removal of Jada)

  4. Time spent in care settings

    Time frame: 24 hours through time of discharge.

    Time spent in care settings (e.g., L&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge

  5. Length of stay

    Time frame: 24 hours through time of discharge.

    Length of stay (LOS) from delivery to discharge

Sponsors and collaborators

Lead sponsor

Alydia Health

Industry

Registry information

Official study title

RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry

Acronym: RUBY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.