Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392366
Status:
COMPLETED
Last Update Posted:
2010-01-01
First Post:
2006-10-24
Brief Title:
Laser Interstitial Thermal Therapy Under Real Time MRI Guidance for Minimal Invasive Treatment of Liver Metastasis
Sponsor:
BioTex Inc
Organization:
BioTex Inc
Study Overview
Official Title:
The Clinical Evaluation of the Laser Interstitial Thermal Therapy LITT Under Real Time MRI Guidance for the Minimal Invasive Treatment of Liver Metastasis - a Phase IIa Mono-centric Study Without Direct Benefice to the Patient
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 MR guided laser interstitial thermal therapy LITT treatment technique can be safety and efficiently used for the human liver metastasis
Detailed Description:
This new minimally invasive technique has been tested so far with success on animal brain and prostate tumors LITT has also tested with success by other teams for the treatment of liver metastasis
The main purpose of this study is to determine if the Visualase MR guided laser interstitial thermal therapy device can be safely and efficiently used for the treatment of human liver metastasis originating from the colon and rectal primary tumors
As secondary objectives for this clinical study is to explore the tolerance of the treatment and its contra indications
The clinical trial will include a statistical sample of 25 patients and will run over a period of 24 months The inclusion period will be of 12 months and the patients will be followed up during a period of 7 days after the intervention
The clinical trial will be performed at the Cochin University Hospital of Paris and the patients will be coming from the oncology surgery departments of the hospital
The patients recruited for this study are those who developed several liver metastasis and are planned for the a surgical resection for part of the liver where metastasis are located Prior to the surgical resection a LITT procedure will be performed on one of the metastasis After the surgical resection histological analysis will be elaborated to compare the real necrosis volume created by the LITT procedure to the expected predicted volume
The main purpose of this study is to determine if the Visualase MR guided laser interstitial thermal therapy device can be safely and efficiently used for the treatment of human liver metastasis originating from the colon and rectal primary tumors
As secondary objectives for this clinical study is to explore the tolerance of the treatment and its contra indications
The clinical trial will include a statistical sample of 25 patients and will run over a period of 24 months The inclusion period will be of 12 months and the patients will be followed up during a period of 7 days after the intervention
The clinical trial will be performed at the Cochin University Hospital of Paris and the patients will be coming from the oncology surgery departments of the hospital
The patients recruited for this study are those who developed several liver metastasis and are planned for the a surgical resection for part of the liver where metastasis are located Prior to the surgical resection a LITT procedure will be performed on one of the metastasis After the surgical resection histological analysis will be elaborated to compare the real necrosis volume created by the LITT procedure to the expected predicted volume
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