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Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

NCT02853500 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-02-05

No results posted yet for this study

Summary

This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients.

The names of the study interventions involved in this study are:

-Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire

Conditions

Interventions

DEVICE

TriNav

TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.

DEVICE

Traditional Delivery

Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.

DRUG

Doxorubicin

Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.

Sponsors & Collaborators

Principal Investigators

  • Dmitry Rabkin, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2025-02-03
Completion
2025-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853500 on ClinicalTrials.gov