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Procedure
End Hole Catheter followed by TriNav Catheter 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following tace
Awards & highlights
Trinav Trial 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.Check my eligibility
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.See study design
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.
Trinav Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Trinav Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following tace
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following tace
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
volume and density of lipiodol
Trinav 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
2 Trials studying Liver Cancer
35 Patients Enrolled for Liver Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,632 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling participants for this medical study?
"The clinical trial mentioned is not currently seeking participants as stated on clinicaltrials.gov. The study was posted on January 15, 2024 and last updated on January 3, 2024. However, it's worth noting that there are presently 759 other studies actively recruiting patients at this time."
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