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Hepatocellular CarcinomaNCT02967523

Surefire Precision Infusion System Registry

An observational study of Hepatocellular Carcinoma, run by Surefire Medical, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
DEB-TACE with Surefire Precision Infusion System
How many people
111 participants
Where
10 sitesUnited States
Study dates
May 2016to 18 Jun 2018
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Maryland Medical Center

    Baltimore, Maryland

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • University Hospitals of Cleveland

    Cleveland, Ohio

  • UCLA

    Los Angeles, California

  • USC

    Los Angeles, California

  • Florida Hospital

    Orlando, Florida

  • University of Utah

    Salt Lake City, Utah

  • UCSD

    San Diego, California

  • Sarasota Memorial Hospital

    Sarasota, Florida

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia

Other trials in United States

About this study

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.

Read the 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.

Being tested
DEB-TACE with Surefire Precision Infusion System
Keywords
Hepatocellular carcinoma, DEB-TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEB-TACE with Surefire Precision Infusion SystemDevice

    Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response

    Measured: 6 months following initial DEB-TACE procedure.

Secondary outcomes (5)

  1. Objective tumor response

    Measured: 1 and 3 months following initial DEB-TACE procedure

  2. Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)

    Measured: 6 months following initial DEB-TACE procedure

  3. Tumor characteristics

    Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)

    Measured: DEB-TACE procedure(s)

  4. Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)

    Measured: DEB-TACE procedure(s)

  5. Changes in alpha-fetoprotein (AFP) blood levels

    Measured: 1, 3 and 6 months following initial DEB-TACE procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion18 Jun 2018
  4. Study completion18 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
111 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967523
Sponsor's protocol ID
26 October 2016
Status last verified
Sep 2018
First submitted
16 Nov 2016
Last updated
11 Sep 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Surefire Medical, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response (time frame: 6 months following initial DEB-TACE procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02967523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.

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Surefire Precision Infusion System Registry | AzTrials