Clinical trial · Observational
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
NCT04272216CI-TRIAL-00094824RAVI RegistrycompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arteriovenous Malformations | — | UNRESOLVED | — |
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Hypervascular Tumors | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment with HydroPearl via radial access | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment with HydroPearl via radial access
- description
- all patients will be in the same group/cohort in this open-label, single-arm, observational registry.
- interventionNames
- Device: Treatment with HydroPearl via radial access
Primary outcomes (4)
- measure
- Procedural Success
- timeFrame
- Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
- description
- Defined as completing the planned procedure without femoral access bailout
- measure
- Technical Success
- timeFrame
- Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is ≥ 18 years old 2. Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access. 3. Subject is willing and able to complete follow-up requirements 4. Subject is willing and able to sign a written Informed Consent form prior to participating in the registry. Exclusion Criteria: 1. Unable to have a procedure with radial access for any reason. 2. Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry. 3. Pregnant or planning to become pregnant during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.