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Clinical Trial Summary

Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy. At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.


Clinical Trial Description

NOVATECH® LUCIOLA™ EB fiducial marker will be implanted near the lung tumor by bronchial endoscopy by a pulmonologist. Following a dosimetry visit, participants will be proposed a maximum of 5 radiation therapy sessions. A follow-up visit at 3 months will take place after the last radiotherapy session. The participation period for each participant will be between 4.5 and 6 months. This study will evaluate the Luciola implant's performance and safety (visibility, migration, complications, tumoral response). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05068973
Study type Interventional
Source Hospital St. Joseph, Marseille, France
Contact Roomila NAECK
Phone 0033786904408
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date July 1, 2023

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