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NCT01651078 · ClinicalTrials.gov registry record
Laser Ablation After Stereotactic Radiosurgery
A clinical trial of Quality of Life and Radiation Necrosis, sponsored by Monteris Medical.
- Completed
- Registry status
- 44
- Enrollment target
- 7
- Study locations
NCT01651078: Completed study of Quality of Life and Radiation Necrosis, sponsored by Monteris Medical.
NCT01651078 is a study of Quality of Life and Radiation Necrosis that has completed, run by Monteris Medical. The registered enrollment target is 44 participants, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01651078, a study of Quality of Life and Radiation Necrosis, has completed, sponsored by Monteris Medical.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are
Conditions Studied
Study Locations (7)
North Carolina
- Carolina Neurosurgery & Spine Associates - Charlotte
- Wake Forest School of Medicine - Winston-Salem
Connecticut
- Yale School of Medicine - New Haven
Kansas
- Kansas University Medical Center - Kansas City
Missouri
- Washington University in St Louis - St Louis
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-08 |
What the finished NCT01651078 record still lists
NCT01651078 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Quality of Life appearing as the primary indexed condition, and to 0 interventions.
NCT01651078 lists 7 locations in 6 states (North Carolina, Connecticut, Kansas).
Frequently Asked Questions
What is clinical trial NCT01651078 about?
NCT01651078 is a clinical study titled "Laser Ablation After Stereotactic Radiosurgery". 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 ...
What is the current status of trial NCT01651078?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2012-07. Estimated completion is 2016-08.
What conditions does trial NCT01651078 study?
This clinical trial studies the following conditions: Quality of Life, Radiation Necrosis, Progression, Metastatic Brain Tumors.
Who is sponsoring clinical trial NCT01651078?
This trial is sponsored by Monteris Medical, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01651078 being conducted?
This trial has 7 study locations across Connecticut, Kansas, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01651078's enrollment target sits among peer trials
44 80th of 107 higher than 28 of 107 other Quality of Life trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Quality of Life trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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