N/A
Completed N=101
EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
hemorrhage · Bleeding Hemorrhage
Source: ClinicalTrials.gov NCT05307783 ↗
Enrolled (actual)
101
Serious AEs
11.9%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours — 100 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours |
100 | — |
| PRIMARY Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs) |
101 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
- Subject provides written informed consent to study data collection.
Exclusion Criteria
- Bleeding site in the neck, head, or brain.
- Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
- In the investigator's opinion, participation in the study may not be in the subject's best interest.
Data sourced from ClinicalTrials.gov (NCT05307783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.