Primary Brain Tumor Clinical Trial
Official title:
Laser Ablation in Stereotactic Neurosurgery
| NCT number | NCT02389855 |
| Other study ID # | LAISE |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2015 |
| Est. completion date | August 2016 |
| Verified date | August 2021 |
| Source | Monteris Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The NeuroBlate® System (NBS), is a 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. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patient was previously treated with NBS - Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent Exclusion Criteria: There are no exclusion criteria for this study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Kansas University Medical Center | Kansas City | Kansas |
| United States | St. Luke's Hospital | Kansas City | Missouri |
| United States | Yale University | New Haven | Connecticut |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Washington University in St. Louis | Saint Louis | Missouri |
| United States | Wake Forest | Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Monteris Medical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status | Retrospective data collection. | up to 24 months | |
| Secondary | Adverse Events | up to 24 months |
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