Clinical trial · Interventional
Surefire Institutional DEB-TACE
Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)
NCT03211598CI-TRIAL-00042939unknownN/AClinicalTrials.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)
The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE with Surefire | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- TACE with Surefire
- description
- Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.
- interventionNames
- Procedure: TACE with Surefire
Primary outcomes (2)
- measure
- Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS.
- timeFrame
- During chemoembolization
- description
- Assess the technical feasibility of performing TACE using the SIS. If stasis of flow is not reached after 1 vial of DEB, further bland embolization will be performed until stasis is reached or earlier as determined adequate by the treating interventional radiologist.
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary liver cancers based on biopsy or imaging criteria 2. Child-Pugh A or B7 liver disease 3. Bilirubin \<2.0 mg/dL 4. Albumin \>3.0 gm/dL 5. ECOG status 0 or 1 6. Adequate renal function a. Creatinine \< 2.0 mg/dL 7. Age 18 or older 8. Able to understand informed consent 9. Life expectancy \> 3 months 10. Women of childbearing potential must have a negative serum/urine pregnancy test on the day of planned procedure. Exclusion Criteria: 1. Portal vein thrombus 2. Uncontrolled ascites 3. Hepatic encephalopathy 4. Uncorrectable coagulopathy (platelets \<50,000, INR \>1.50) 5. Untreatable contrast allergy 6. Pregnancy 7. Symptomatic congestive heart failure 8. Prior systematic therapy for HCC
References
Publications (1)
- BACKGROUNDLee KK, Kim DG, Moon IS, Lee MD, Park JH. Liver transplantation versus liver resection for the treatment of hepatocellular carcinoma. J Surg Oncol. 2010 Jan 1;101(1):47-53. doi: 10.1002/jso.21415. PMID 19798686