Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02294903
Status:
UNKNOWN
Last Update Posted:
2018-04-24
First Post:
2014-11-15
Brief Title:
Focal Prostate Radiofrequency Ablation
Sponsor:
Trod Medical NV
Organization:
Trod Medical NV
Study Overview
Official Title:
A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
ACTIVE_NOT_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:
ProRAFT
Brief Summary:
To assess the early histological outcomes of tissue ablation adverse events and genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar device to treat localized prostate cancer in men with clinically significant prostate cancer
Detailed Description:
The study aims to assess the ability of focal therapy using coiled bipolar radiofrequency device to ablate a pre-defined target tissue zone as well as assess side-effects The medical device has a coiled configuration and creates thus a Faraday cage effect preventing surrounding tissue damage and the bipolar configuration produces complete tissue thermo coagulation within the limits the coil
Thereof it is proposed to conduct a prospective development study offering focal therapy coiled bipolar radiofrequency ablation to men with histologically proven localized prostate cancer which is clinically significant
Localization and characterization of the disease will be established using multi-parametric magnetic resonance imaging mp-MRI and transperineal prostate biopsies Magnetic resonance MR-visible clinically significant disease will be targeted and focally treated with a margin of normal tissue as big as anatomically possible to obtain an adequate margin of normal tissue around the lesion for effective ablation Secondary lesions meeting criteria for clinical insignificance will be left untreated and undergo surveillance
Pre-operative and all post operative imaging will be performed using a scanner and a pelvic phased array receiver with a pelvic coil A full protocol of T1 and T2 weighted turbo-spin echo images and a dynamic post gadolinium volume acquisition will be used for both pre-operative diagnostic and planning scans and post-operative assessment by use of the medical device
The initial transperineal biopsy will already have been performed prior to invitation to participate in the study and demonstrating eligibility for inclusion
The process will involve targeted or mapping biopsies which are concordant with the lesion seen on MRI In both cases transperineal biopsies will be taken from the prostate using a brachytherapy grid placed over the perineal skin whilst the man is in the lithotomy position
They will be given as much time as they need to consider whether or not patients wish to participate The ones who wish to participate after reading the patient information sheet will undergo a screening visit first visit to ascertain whether or not they are eligible for the trial If so they will proceed to focal radiofrequency ablation using a coiled bipolar devicesecond visit and will be seen at further follow-up visits
Thereof it is proposed to conduct a prospective development study offering focal therapy coiled bipolar radiofrequency ablation to men with histologically proven localized prostate cancer which is clinically significant
Localization and characterization of the disease will be established using multi-parametric magnetic resonance imaging mp-MRI and transperineal prostate biopsies Magnetic resonance MR-visible clinically significant disease will be targeted and focally treated with a margin of normal tissue as big as anatomically possible to obtain an adequate margin of normal tissue around the lesion for effective ablation Secondary lesions meeting criteria for clinical insignificance will be left untreated and undergo surveillance
Pre-operative and all post operative imaging will be performed using a scanner and a pelvic phased array receiver with a pelvic coil A full protocol of T1 and T2 weighted turbo-spin echo images and a dynamic post gadolinium volume acquisition will be used for both pre-operative diagnostic and planning scans and post-operative assessment by use of the medical device
The initial transperineal biopsy will already have been performed prior to invitation to participate in the study and demonstrating eligibility for inclusion
The process will involve targeted or mapping biopsies which are concordant with the lesion seen on MRI In both cases transperineal biopsies will be taken from the prostate using a brachytherapy grid placed over the perineal skin whilst the man is in the lithotomy position
They will be given as much time as they need to consider whether or not patients wish to participate The ones who wish to participate after reading the patient information sheet will undergo a screening visit first visit to ascertain whether or not they are eligible for the trial If so they will proceed to focal radiofrequency ablation using a coiled bipolar devicesecond visit and will be seen at further follow-up visits
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