CLINICAL RESEARCH & EVIDENCE
Industry-leading Commitment to Clinical Research
We are driven to improve and extend the life of patients suffering from neurological diseases by providing a minimally invasive option for patients. Our commitment to clinical research is an essential and integral part of our mission and is demonstrated in our clinical trial work and the resulting clinical evidence.
NeuroBlate Clinical Evidence
Monteris Medical has sponsored the collection of acute and long-term outcomes with the NeuroBlate System across eight clinical studies.1 All currently enrolling studies are conducted under post-market protocols due to the commercial nature of the device.
LITT Clinical Evidence
Published data has greatly expanded in recent years. Prospective outcomes for Laser Interstitial Thermal Therapy (LITT) are published for brain tumors, radiation necrosis and drug-resistant epilepsy.
Download a copy of a LITT Bibliography.
Clinical Guidelines and Societal Recommendations on LITT
The National Comprehensive Cancer Network® (NCCN) issued guidelines on the use of LITT (Central Nervous System Cancers, V1.2023, BRAIN-B), indicating LITT may be considered for patients who are poor surgical candidates (craniotomy or resection). Potential indications include recurrent brain metastases, radiation necrosis and recurrent glioblastoma.
Societal recommendations supporting the use of LITT for people with brain tumors and drug-resistant epilepsy have been issued by the American Association of Neurological Surgeons (AANS), the College of Neurological Surgeons (CNS), and the American Society of Stereotactic and Functional Neurosurgery (ASSFN). Because updates to the medical guidelines can take several years, the joint position statements represent an evidence-based summary and the societies’ current thinking, to guide health care providers in the use of magnetic resonance (MR)-guided LITT for the management of selected patients who may benefit from a minimally invasive laser procedure.
REMASTer: Randomized Controlled Trial (NCT05124912)
The Recurrent Brain Metastases After SRS Trial (REMASTer) study is a randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of radiographic progression evidence after stereotactic radiosurgery (SRS), with or without resection. Currently Enrolling.
For information about the study, visit: https://clinicaltrials.gov/ct2/show/NCT05124912
LAANTERN: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System Trial (NCT02392078)
Monteris is the sponsor of the largest laser ablation registry for brain: LAANTERN—a prospective, multi-center study of outcomes for patients undergoing the NeuroBlate procedure. LAANTERN enrolled over 1,000 patients in the United States and Canada and followed them for a 5-year period. Not currently enrolling.
LAANTERN study has produced a number of peer-reviewed publications highlighting NeuroBlate® utilization, safety, quality of life, health economics, and procedural outcomes including survival and seizure freedom. Published articles from LAANTERN:
Efficacy of laser interstitial thermal therapy for biopsy-proven radiation necrosis in radiographically recurrent brain metastases
Chan M, Tatter S, Chiang V, et al. Neuro-Oncology Advances, Volume 5, Issue 1, January-December 2023.
Efficacy of Laser Interstitial Thermal Therapy (LITT) for Newly Diagnosed and Recurrent IDH Wild-type Glioblastoma
de Groot J, Kim A, Prabhu S, Rao G, et al. Neuro-Oncology Advances, Volume 4, Issue 1, January-December 2022.
Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12- month outcomes and quality of life after brain tumor ablation
Kim AH, Tatter S, Rao G, et al. Neurosurgery: September 2020 – Volume 87 – Issue 3 – p E338-E346.
A prospective multicenter study of laser ablation for drug resistant epilepsy – One year outcomes
Landazuri P, Shih J, Leuthardt E, et al. Epilepsy Research, Volume 167, 2020, 106473.
Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): procedural safety and hospitalization
Rennert RC, Khan U, Bartek J, et al. Neurosurgery: April 2020 – Volume 86 – Issue 4 – p 538-547.
Patterns of clinical use of stereotactic laser ablation: analysis of a multicenter prospective registry
Rennert RC, Khan U, Tatter SB, et al. World Neurosurgery, Volume 116, August 2018, p E566-E570.
PENSAR: Neurocognitive Outcomes Trial (NCT05075850)
The Patient Neuropsychological Outcomes After Laser Ablation (PENSAR) study is a multi-center sub-study for the LAANTERN registry that will include comprehensive neuropsychological assessment data collection. Not currently enrolling.
Investigator Initiated Research Support
Monteris has an active investigator initiated research program, which allows us to partner with investigators in their LITT early phase research. For more information contact email@example.com.
Monteris provides technology for neurosurgeons, which allows them to ablate (destroy with heat), brain structures such as brain tumors, radiation necrosis, and epileptic foci. Monteris technology includes the NeuroBlate System, AtamA, and MiniBolt devices, which may be used together to apply the focused laser energy with little or no effect on surrounding healthy tissue. The NeuroBlate System provides clinicians a tool that offers near real-time control and MRI visualization of the therapy during laser ablation treatment.
All brain surgeries carry risk. Possible adverse events include, but are not limited to, hematoma, embolic events, edema, bleeding, cerebral spinal fluid (CSF) leakage, infection, unintended major tissue damage and permanent neurological deficits. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
1. NCT00747253 (2008-2010), NCT01651078 (2012-2016), NCT02389855 (2015-2016), NCT02880410 (2017-2018), NCT02820740 (2017-2019), NCT02392078 (2015-present), NCT05075850 (2021-present), NCT05124912 (2021-present)