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Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules. — SATAN  

Lung Cancer Clinical Trial

Official title:
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.

Clinical Trial Summary

The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.

Clinical Trial Description

Due to the improvement of screening techniques, the detection of peripheral and isolated lesions is an increasingly frequent situation. However these SPN cause difficulties in obtaining a sample. Indeed, current endoscopic techniques remain insufficient in terms of performance. Moreover, computed tomography-guided percutaneous needle biopsy despite a very good sensitivity has many limitations related to the size of the lesions, the accessibility and important complications. The Archimedes® system is an improved version of LungPoint® and combines 3D reconstruction of chest images with intraoperative radioscopy. It uses a catheter to access through the bronchial wall the pulmonary parenchyma and navigate to the SPN. All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections. A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology. The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia. Immediate monitoring consisted in a chest x-ray 1hour after the procedure. Patients' participation in the study will stop once they benefit from their thoracic surgery ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04140474
Study type Interventional
Source University Hospital, Limoges
Contact
Status Terminated
Phase N/A
Start date January 21, 2021
Completion date July 1, 2021
View Details
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