NCT04140474

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Bronchoscopy
• Lung Cancer
• Solitary Pulmonary Nodule

Interventions

Type	Name	Description
DEVICE	Archimedes procedure	All patients will initially have a scanner necessary for planning by the Archimedes system of the tunneling path. each patient will then undergo a general anesthesia as for any bronchoscopy. Then start the Archimedes procedure itself to reach the SPN

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-10-28
• Last updated: 2021-09-14

Locations

1 site across 1 country: France