Laser Ablation After Stereotactic Radiosurgery for Patients With Metastatic Brain Tumors. (LAASR)
The need for new technologies and devices in the field of neurosurgery is well-established. In addition to the advanced engineering and medical aspects of a newly available medical device, the adoption and incorporation of such a device into healthcare organizations greatly influences it's impact on patients. As the FDA cleared NeuroBlate™ System (formerly called AutoLITT®; a minimally invasive neurosurgical device) is a new to the marketplace, there is limited experience as to how such a system is best used by healthcare organizations. This (a) post-marketing, multi-site, (b) open-label study involving (c) a single cohort of brain tumor patients that undergo routine NeuroBlate procedures is aimed at collecting, in a reasonably controlled fashion, such descriptive information, and comparing the collected information on patient Quality of Life (QoL) and healthcare utilization to published and historical information.
Metastatic Brain Tumors
Quality of Life
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Laser Ablation After Stereotactic Radiosurgery. A Post-Marketing Surveillance (Phase IV) Multicenter Observational Study.|
- Quality of Life [ Time Frame: Pre-surgery, and up to 4 points along 6 mo follow-up ] [ Designated as safety issue: No ]FACT-Br Standardized Patient Reporting Instrument will be used to assess changes (relative to baseline) in Quality of Life during 6 month follow-up (post surgery)
- Radiographic Progression [ Time Frame: 1, 2, 4, 12, 26 weeks post-surgery ] [ Designated as safety issue: Yes ]Standard clinical MRI scans will be assessed during the follow-up period. Assessment will be for evidence of disease progression and other indicators of treatment effect.
- Adverse Events [ Time Frame: throughout study (pre-op through 6 mo follow-up) ] [ Designated as safety issue: Yes ]CTAE 4 Adverse events will be recorded and analyzed.
- Utilization of Healthcare Resources [ Time Frame: Throughout study, collected at end of patient involvement. ] [ Designated as safety issue: No ]Various aspects of the clinical and non-clinical services required/utilized by the patient cohort will be collected and analyzed.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Patients (from normal clinical population) whom are scheduled for NeuroBlate/AutoLITT surgery to treat metastatic brain tumors previously treated with Stereotactic Radiosurgery (SRS), but have developed progression or radiation necrosis of SRS treated tumors.
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Gene H. Barnett, MD 216.445.1379 firstname.lastname@example.org|
|Principal Investigator: Gene H. Barnett, MD, MBA, FACS|
|Principal Investigator:||Gene H. Barnett, MD, MBA, FACS||The Cleveland Clinic|