Primary Brain TumorNCT02389855
Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry
An observational study of Primary Brain Tumor, run by Monteris Medical at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Brain Tumor
- What is being tested?
- NeuroBlate® System Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 144 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously treated with NBS (up to 300)
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
St. Luke's Hospital
Kansas City, Missouri, 64111
Yale University
New Haven, Connecticut, 06520
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Wake Forest
Salem, North Carolina, 27157
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Laser Ablation in Stereotactic Neurosurgery
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.
- Conditions
- Primary Brain Tumor
- Being tested
- NeuroBlate® System Therapy
- Keywords
- Progression, Quality of Life
- Medical subject headings
- Brain Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroBlate® System TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
Retrospective data collection.
Measured: up to 24 months
Secondary outcomes (1)
Adverse Events
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monteris Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sujit Prabu, MD, PhD, Principal investigator, M.D. Anderson Cancer CenterAndrew Sloan, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389855
- Sponsor's protocol ID
- LAISE
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2015
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Ablation in Stereotactic Neurosurgery
- ClinicalTrials.gov ID
- NCT02389855
- Acronym / sponsor ID
- LAISE
- Conditions
- Primary Brain Tumor
- Keywords
- Progression, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Monteris MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously treated with NBS (up to 300)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroBlate® System Therapy | Procedure or surgery | – |
Primary outcome
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
Time frame: up to 24 months
Retrospective data collection.
1 secondary outcome
Adverse Events
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujit Prabu, MD, PhD principal investigator
M.D. Anderson Cancer Center
Andrew Sloan, MD, PhD principal investigator
University Hospitals Cleveland Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor, run by Monteris Medical at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.