Surefire Precision Infusion System Registry
1 other identifier
observational
111
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2018
CompletedSeptember 11, 2018
September 1, 2018
2.1 years
November 16, 2016
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective tumor response
6 months following initial DEB-TACE procedure.
Secondary Outcomes (5)
Objective tumor response
1 and 3 months following initial DEB-TACE procedure
Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
6 months following initial DEB-TACE procedure
Tumor characteristics
DEB-TACE procedure(s)
Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)
DEB-TACE procedure(s)
Changes in alpha-fetoprotein (AFP) blood levels
1, 3 and 6 months following initial DEB-TACE procedure
Interventions
Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.
Eligibility Criteria
Patients who have been diagnosed with HCC in which the Surefire Precision Infusion System was used/will be used to deliver DEB-TACE.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
UCLA
Los Angeles, California, United States
USC
Los Angeles, California, United States
UCSD
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baljendra Kapoor, MD
The Cleveland Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 18, 2016
Study Start
May 1, 2016
Primary Completion
June 18, 2018
Study Completion
June 18, 2018
Last Updated
September 11, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share