Surefire Precision Infusion System Registry

September 10, 2018 updated by: Surefire Medical, Inc.
This project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision Infusion System was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). The best results for cTACE occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.

DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • UCLA
      • Los Angeles, California, United States
        • USC
      • San Diego, California, United States
        • UCSD
    • District of Columbia
      • Washington, District of Columbia, United States
        • MedStar Georgetown University Hospital
    • Florida
      • Orlando, Florida, United States
        • Florida Hospital
      • Sarasota, Florida, United States
        • Sarasota Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland Medical Center
    • Ohio
      • Cleveland, Ohio, United States
        • University Hospitals of Cleveland
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed with HCC in which the Surefire Precision Infusion System was used/will be used to deliver DEB-TACE.

Description

Inclusion Criteria:

  • Patients who have undergone or will undergo DEB-TACE for HCC delivered by the Surefire® Precision Infusion System
  • Patients aged 18 years or older
  • Diagnosis of HCC
  • Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥ 1.5 mm

Exclusion Criteria:

  • Contraindications for doxorubicin administration
  • Vessels providing flow to the tumor that are < 1.5 mm in diameter(s)
  • Patients who are unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response
Time Frame: 6 months following initial DEB-TACE procedure.
6 months following initial DEB-TACE procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective tumor response
Time Frame: 1 and 3 months following initial DEB-TACE procedure
1 and 3 months following initial DEB-TACE procedure
Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
Time Frame: 6 months following initial DEB-TACE procedure
6 months following initial DEB-TACE procedure
Tumor characteristics
Time Frame: DEB-TACE procedure(s)
Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)
DEB-TACE procedure(s)
Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)
Time Frame: DEB-TACE procedure(s)
DEB-TACE procedure(s)
Changes in alpha-fetoprotein (AFP) blood levels
Time Frame: 1, 3 and 6 months following initial DEB-TACE procedure
1, 3 and 6 months following initial DEB-TACE procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surefire Medical, Inc.

Investigators

  • Principal Investigator: Baljendra Kapoor, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

June 18, 2018

Study Completion (ACTUAL)

June 18, 2018

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (ESTIMATE)

November 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26 October 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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