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Procedure

TACE Catheters for Liver Cancer (Trinav Trial)

N/A
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Plan to undergo lipiodol TACE for HCC or NET liver metastases
Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
Must not have
Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following tace
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the use of two different catheters during a procedure called TACE, which is used to treat tumors. The goal is to see if there is a difference in the appearance of

Who is the study for?
This trial is for individuals with carcinoid tumors, liver cancer, neuroendocrine tumors, or liver tumors who are candidates for a TACE procedure. Specific eligibility criteria details were not provided.
What is being tested?
The study aims to compare the effectiveness of two FDA-approved catheters (End Hole and TriNav) used in TACE procedures by examining CT scans to see how well each covers the treated tumors.
What are the potential side effects?
Potential side effects were not detailed but may include those typically associated with Transarterial Chemoembolization (TACE) such as abdominal pain, fever, nausea, and complications related to catheter use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific liver cancer treatment using lipiodol.
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My liver cancer requires multiple targeted treatments.
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Less than half of my liver is affected by cancer.
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My main portal vein is open and not blocked.
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My blood platelet count is healthy and my kidneys are functioning well.
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My liver is functioning within the required levels.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have iodine-based contrast due to a severe past reaction.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have had surgery or a procedure to open my bile duct.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following tace
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following tace for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
volume and density of lipiodol

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: TriNav Catheter followed by End Hole CatheterExperimental Treatment1 Intervention
FDA approved catheter Randomization TriNav catheter then End Hold catheter
Group II: End Hole Catheter followed by TriNav CatheterExperimental Treatment1 Intervention
FDA approved catheter Randomization End Hole catheter then TriNav catheter

Find a Location

Who is running the clinical trial?

TriSalus Life SciencesUNKNOWN
3 Previous Clinical Trials
35 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
415 Previous Clinical Trials
464,694 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
212 Patients Enrolled for Neuroendocrine Tumors
~7 spots leftby Jan 2026
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