EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-04-10

Brief Summary

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This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.

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Detailed Description

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Conditions

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Hemorrhage Bleeding Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EmboCube Embolization Gelatin

EmboCube is a uniformly cut gelatin foam pre-loaded into a syringe, indicated for use in embolization of blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
3. Subject provides written informed consent to study data collection.

Exclusion Criteria

1. Bleeding site in the neck, head, or brain.
2. Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
3. In the investigator's opinion, participation in the study may not be in the subject's best interest.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No