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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 is a clinical trial that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055688
The ClinicalTrials.gov registry entry for NCT04055688 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Orbeye surgical videomicroscope is the first listed.
NCT04055688 reports 0 study locations.
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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