Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients
NCT05068973 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2023-01-27
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.
Conditions
Interventions
- DEVICE
-
NOVATECH® LUCIOLA™ EB - (Fiducial Marker)
Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker
Sponsors & Collaborators
-
NOVATECH SA
collaborator UNKNOWN -
Hospital St. Joseph, Marseille, France
lead OTHER
Principal Investigators
-
Bruno Escarguel, MD · Hôpital Saint Joseph, Marseille France
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-18
- Primary Completion
- 2024-09-01
- Completion
- 2025-03-01
Countries
- France
Study Locations
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