Laser Ablation After Stereotactic Radiosurgery (LAASR)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Monteris Medical Identifier:
First received: July 24, 2012
Last updated: January 27, 2016
Last verified: January 2016
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.

Metastatic Brain Tumors
Radiation Necrosis
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation After Stereotactic Radiosurgery

Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • Progression-Free Survival Rate [ Time Frame: 12 and 26 weeks post index procedure ] [ Designated as safety issue: No ]
    To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12 and 26 weeks post index procedure ] [ Designated as safety issue: Yes ]
    To assess the neurocognitive effects of NeuroBlate via Quality of Life and neurocognitive assessment tools

  • Overall Survival [ Time Frame: 12 and 26 weeks post index procedure ] [ Designated as safety issue: No ]
    To describe/estimate the overall survival

  • Adverse Events [ Time Frame: 12 and 26 weeks post index procedure ] [ Designated as safety issue: Yes ]
    To continue to monitor factors impacting the safe and efficacious use of NeuroBlate

Enrollment: 44
Study Start Date: July 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with radiographic evidence of lesion regrowth following prior treatment with radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radionecrosis).

Key Inclusion Criteria:

  1. Patient has signed and received a copy of the Informed Consent Form
  2. 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.
  3. Karnofsky Performance Status (KPS) ≥ 60.

Key Exclusion Criteria:

  1. Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.
  2. Leptomeningeal metastases.
  3. Uncontrolled infectious process.
  4. Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.
  5. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
  6. Abnormal absolute neutrophil count (ANC<1000/mm), platelets (<100,000/mm) or the administration of antiplatelet agents (aspirin, plavix etc) or anticoagulation within 7 days prior to treatment.
  7. Inadequate bone marrow, liver and renal function (e.g., total bilirubin > 1.5 x ULN; AST, ALT > 2.5 x ULN; alkaline phosphatase > 2.5 x ULN; serum creatinine > 1.5 x ULN).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01651078

United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University in St Louis
St. Louis, Missouri, United States, 63110
United States, North Carolina
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States, 28204
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Monteris Medical
Principal Investigator: Veronica Chiang, MD Yale School of Medicine
  More Information

Responsible Party: Monteris Medical Identifier: NCT01651078     History of Changes
Other Study ID Numbers: LAASR 
Study First Received: July 24, 2012
Last Updated: January 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Monteris Medical:
Metastatic Brain Tumors
Radiation Necrosis
Quality of Life

Additional relevant MeSH terms:
Brain Neoplasms
Disease Progression
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Disease Attributes
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes processed this record on May 26, 2016