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Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

NCT04055688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-05-31

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Orbeye surgical videomicroscope

The ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation.

DRUG

5-Aminolevulinic Acid

5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes.

Sponsors & Collaborators

  • Olympus Corporation

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Michael A Vogelbaum, MD, PhD · H. Lee Moffitt Cancer and Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2019-12-17
Completion
2021-02-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055688 on ClinicalTrials.gov