NCT00514930

Brief Summary

The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
Last Updated

August 10, 2007

Status Verified

August 1, 2007

First QC Date

August 9, 2007

Last Update Submit

August 9, 2007

Conditions

Liver Cancer

Keywords

radiofrequency ablationliver cancercomplicationsliver tumors

Outcome Measures

Primary Outcomes (1)

  • To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.

    2 years

Secondary Outcomes (1)

  • Complications and unexpected adverse events (early and late) related to RFA aspirator treatment to be assessed. Data points to be collected as per proforma for trial.

    2 years

Interventions

HexablateDEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants will be 18 years and older.
  • Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location.

You may not qualify if:

  • Age younger than 18 years old
  • Pregnant women
  • Uncorrectable coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

C. Hatzitheofilou

Larissa, 41110, Greece

RECRUITING

Related Publications (1)

  • Zacharoulis D, Khorsandi SE, Vavra P, Dostalik J, Navarra G, Nicholls JP, Jiao LR, Habib NA. Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers. Liver Int. 2009 Jul;29(6):824-30. doi: 10.1111/j.1478-3231.2008.01910.x.

    PMID: 19638109DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Dimitris Zacharoulis, M.D.

    University of Thessaly

    PRINCIPAL INVESTIGATOR

  • Nagy Habib, Professor

    Imperial College London U.K.

    STUDY CHAIR

  • Giuseppe Navarra, Professor

    University of Messina

    STUDY DIRECTOR

Central Study Contacts

Dimitris Zacharoulis, Assistant Professor

CONTACT

+30-2410-682803zachadim@yahoo.com

Nagy Habib, Professor of Surgery

CONTACT

Tel: +44 (0) 20 83832033 / (0)nagy.habib@imperial.ac.uk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

February 1, 2007

Study Completion

August 1, 2007

Last Updated

August 10, 2007

Record last verified: 2007-08

Locations

GR(1)