Laser Ablation After Stereotactic Radiosurgery

Status: Completed
Location: See all (7) locations...
Study Type: Observational
SUMMARY

The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient has signed and received a copy of the Informed Consent Form

• Patient may have up to 3 target supratentorial metastatic lesions previously treated with stereotactic radiosurgery, with radiological evidence of progression, pseudoprogression or radionecrosis. Subject may have additional non target lesions present as long as they are not expected (in Investigator's judgment) to contribute to symptomatology during the course of the study or confound interpretation of radiological and clinical measures.

• Karnofsky Performance Status (KPS) ≥ 60.

Locations
United States
Connecticut
Yale School of Medicine
New Haven
Kansas
Kansas University Medical Center
Kansas City
Missouri
Washington University in St Louis
Saint Louis
North Carolina
Carolina Neurosurgery & Spine Associates
Charlotte
Wake Forest School of Medicine
Winston-salem
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
Thomas Jefferson University
Philadelphia
Time Frame
Start Date: July 2012
Completion Date: August 2016
Participants
Target number of participants: 44
Treatments
Main cohort
Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.
Sponsors
Leads: Monteris Medical

This content was sourced from clinicaltrials.gov

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