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Chemotherapy

Surefire Institutional DEB-TACE

N/A
Waitlist Available
Led By Alexander Y Kim, MD
Research Sponsored by Alexander Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (12 months)
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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.
Secondary study objectives
FACT Hep4 Questionnaire
Tumor Assessment via CT Imaging
Tumor Assessment via MRI Imaging

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TACE with SurefireExperimental Treatment1 Intervention
Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.

Find a Location

Who is running the clinical trial?

Surefire Medical, Inc.Industry Sponsor
5 Previous Clinical Trials
300 Total Patients Enrolled
Alexander KimLead Sponsor
Alexander Y Kim, MDPrincipal InvestigatorMedStar Georgetown University Hospital
~2 spots leftby Dec 2025
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