NCT02853500

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter. TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter).

Conditions

• Liver Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2016-08-03
• Last updated: 2025-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study