Clinical trial · Interventional
Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study
Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient number of subjects meeting inclusion criteria
Summary
Brief summary (as posted)
The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard End-hole catheter | Device | — | UNRESOLVED |
| Surefire® Infusion System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surefire® Infusion System
- description
- Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.
- interventionNames
- Device: Surefire® Infusion System
- type
- ACTIVE_COMPARATOR
- label
- Standard End-hole catheter
- description
- Patients randomized to the standard end-hole catheter treatment arm will undergo Y-90 glass microsphere embolization with a standard end-hole catheter.
- interventionNames
- Device: Standard End-hole catheter
Primary outcomes (1)
- measure
- Y-90 distribution and concentration as determined by post embolization PET-CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Lobar-only treatments * Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy * Patients 18 years of age and older * Patients who are able to provide written informed consent Exclusion Criteria: * Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease, * Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, * Patients who are unable to tolerate Y-90, * Patients with arterial anatomy unsuitable to place Surefire catheter, * Patients with uncorrectable coagulopathy, * Patients with platelets less than 50 (uncorrectable), * Bilirubin \>3 mg/dl, * AST or ALT\>5x upper limit of normal, * Patients who are unable to tolerate angiography, * Patients with \< 3 months to live, * Patients who meet the standard Y-90 exclusion criteria according to package insert * Female patients who are pregnant * Patients under the age of 18 * Patients who are unable to provide written informed consent
References
Publications (1)
- BACKGROUNDArepally A, Chomas J, Kraitchman D, Hong K. Quantification and reduction of reflux during embolotherapy using an antireflux catheter and tantalum microspheres: ex vivo analysis. J Vasc Interv Radiol. 2013 Apr;24(4):575-80. doi: 10.1016/j.jvir.2012.12.018. Epub 2013 Feb 23. PMID 23462064