Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392119
Status:
COMPLETED
Last Update Posted:
2010-01-01
First Post:
2006-10-23
Brief Title:
MR Guided Laser Interstitial Thermal Therapy for the Minimal Invasive Treatment of Brain Metastasis and Primary Brain Tumors
Sponsor:
BioTex Inc
Organization:
BioTex Inc
Study Overview
Official Title:
The Clinical Evaluation of the Stereotactic MR Guided Laser Interstitial Thermal Therapy LITT for the Minimal Invasive Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
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 purpose of this study is to determine if the stereotactic MR guided laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors
Detailed Description:
This new minimally invasive technique has been tested so far with success on animal brain tumor models and on human liver metastasis
The main purpose of this study is to determine if the stereotactic MR guided laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors
As secondary objectives for this clinical study the following are to be explored
Eventual evaluation of the eventual mid and long term post-intervention complications
Evaluate the contra indication for the technique
Evaluate and optimize clinical and logistic intervention protocols
Evaluate the mean duration for the procedure
Evaluate the mean cost for the procedure
The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention
The clinical trial will be performed at the Lariboisiere University Hospital of Paris and the patients will be coming from all the Assistance Publique de Paris APHP hospitals
The main purpose of this study is to determine if the stereotactic MR guided laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors
As secondary objectives for this clinical study the following are to be explored
Eventual evaluation of the eventual mid and long term post-intervention complications
Evaluate the contra indication for the technique
Evaluate and optimize clinical and logistic intervention protocols
Evaluate the mean duration for the procedure
Evaluate the mean cost for the procedure
The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention
The clinical trial will be performed at the Lariboisiere University Hospital of Paris and the patients will be coming from all the Assistance Publique de Paris APHP hospitals
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