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NCT04055688 · ClinicalTrials.gov registry record
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
A clinical trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- 20
- Enrollment target
NCT04055688: Completed study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04055688 is a clinical trial that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055688 has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients. This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
Primary Outcome
6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE
Interventions
- DEVICE Orbeye surgical videomicroscope
- DRUG 5-Aminolevulinic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2021-02-23 |
What the finished NCT04055688 record still lists
NCT04055688 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Orbeye surgical videomicroscope is the first listed.
NCT04055688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04055688 about?
NCT04055688 is a clinical study titled "Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas". 5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this stu...
What is the current status of trial NCT04055688?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2019-08-15. Estimated completion is 2021-02-23.
What interventions are being tested in trial NCT04055688?
The interventions under investigation include: Orbeye surgical videomicroscope (DEVICE), 5-Aminolevulinic Acid (DRUG).
Who is sponsoring clinical trial NCT04055688?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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