Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514930
Status:
UNKNOWN
Last Update Posted:
2007-08-10
First Post:
2007-08-09
Brief Title:
Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency AblationAspirator Device Hexablate in the Management of Primary and Secondary Liver Cancers
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Patients with unresectable primary or secondary malignancies of the liver have limited treatment options which often only give a small survival benefit RFA has been demonstrated to be effective in local tumour eradication and to extend patient survival In this study RFA aspiration will be used to treat unresectable primary or secondary tumours of the liver RFA will be used to develop a shell of tissue destruction around the tumour with aspiration removing tissue and fluid from the centre of the lesion The potential advantages of aspirating during ablation could be to reduce aerosol spread of tumour within the liver parenchyma and peritoneum Additionally aspirating the ablated tissue may reduce the incidence of systemic side effects related to RFA when larger lesions are treated This study would establish the safety and efficiacy of RFA aspiration in the treatment of unresectable primarysecondary malignancies of the liver
This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primarysecondary malignancies of the liver which are not suitable for formal liver resection The basis for unresectability being the presence of extra-hepatic disease limited liver synthetic function co-morbidity ASA3 bilobar disease and anatomical location Early and late complications relating to the usage of the RFA aspirator will be analysed Additionally local recurrence and long term survival will be assessed If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality Then these initial results will justify further in depth studies to establish its clinical role
II SPECIFIC AIMSOBJECTIVES
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
III STUDY OVERVIEW
It is anticipated that 100-200 participants will be recruited The time period for patient recruitment will be for 2 years with follow up for 3 years The total study period will be 5 years in order to allow the assessment of complications local ablation success and survival benefit
This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primarysecondary malignancies of the liver which are not suitable for formal liver resection The basis for unresectability being the presence of extra-hepatic disease limited liver synthetic function co-morbidity ASA3 bilobar disease and anatomical location Early and late complications relating to the usage of the RFA aspirator will be analysed Additionally local recurrence and long term survival will be assessed If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality Then these initial results will justify further in depth studies to establish its clinical role
II SPECIFIC AIMSOBJECTIVES
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
III STUDY OVERVIEW
It is anticipated that 100-200 participants will be recruited The time period for patient recruitment will be for 2 years with follow up for 3 years The total study period will be 5 years in order to allow the assessment of complications local ablation success and survival benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None