RUBY Post-Market Registry on the Jada® System

Alydia Health

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Device: Jada® System

Study type: Observational

Funder types: Industry

Identifiers

NCT04995887

CIP-05 v1.0

Protocol No. PPH-05 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 809 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

NOTE: There is no Exclusion Criteria in this protocol.

Trial design

809 participants in 4 patient groups

C-Section Delivery with EBL ≥ 1500 mL

Description:

Patients with ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).

Treatment:

Device: Jada® System

C-Section Delivery with EBL < 1500 mL

Description:

Patients with \< 1500 mL EBL at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).

Treatment:

Device: Jada® System

Vaginal Delivery with EBL ≥ 1000 mL

Description:

Patients with ≥ 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).

Treatment:

Device: Jada® System

Vaginal Delivery with EBL < 1000 mL

Description:

Patients with \< 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first).

Treatment:

Device: Jada® System