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NCT04055688
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
trial testing Orbeye surgical videomicroscope in Brain Tumor in 20 participants. Completed in 23 February 2021.
17 December 2019
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 15 August 2019 |
| Primary completion | 17 December 2019 |
| Estimated completion | 23 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Orbeye surgical videomicroscope
- 5-Aminolevulinic Acid
Conditions studied
- Brain Tumor — all drugs for Brain Tumor →
- Glioma — all drugs for Glioma →
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Brain Tumor or Glioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intraoperative glioblastoma surgery-current challenges and clinical trials: An update.
Patel V, Chavda V. · · 2024 · cited 14× · PMID 39371095 · DOI 10.1016/j.cpt.2023.11.006
Verify or expand the search:
- PubMed search for NCT04055688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04055688 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 31 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04055688.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing