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Surefire Precision Infusion System Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Surefire Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02967523
First received: November 16, 2016
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Hepatocellular Carcinoma Device: DEB-TACE with Surefire Precision Infusion System

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Target Follow-Up Duration: 6 Months
Official Title: Surefire Precision Infusion System Registry

Further study details as provided by Surefire Medical, Inc.:

Primary Outcome Measures:
  • Objective tumor response [ Time Frame: 6 months following initial DEB-TACE procedure. ]

Secondary Outcome Measures:
  • Objective tumor response [ Time Frame: 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 ]
  • 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)

  • Size of doxorubicin-eluting beads used during DEB-TACE procedure(s) [ Time Frame: DEB-TACE procedure(s) ]
  • Changes in alpha-fetoprotein (AFP) blood levels [ Time Frame: 1, 3 and 6 months following initial DEB-TACE procedure ]

Estimated Enrollment: 150
Study Start Date: May 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DEB-TACE with Surefire Precision Infusion System
    Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02967523

Sponsors and Collaborators
Surefire Medical, Inc.
Investigators
Principal Investigator: Baljendra Kapoor, MD The Cleveland Clinic
  More Information

Responsible Party: Surefire Medical, Inc.
ClinicalTrials.gov Identifier: NCT02967523     History of Changes
Other Study ID Numbers: 26 October 2016
Study First Received: November 16, 2016
Last Updated: November 17, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Surefire Medical, Inc.:
Hepatocellular carcinoma
DEB-TACE

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on June 23, 2017