Clinical trial · Interventional
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
NCT04140474CI-TRIAL-00053885SATANterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inclusion difficulties
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchoscopy | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archimedes procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Archimedes procedure
- description
- 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.
- interventionNames
- Device: Archimedes procedure
Primary outcomes (1)
- measure
- Number of diagnostics obtained with the Archimedes system
- timeFrame
- Month 1
- description
- It will be the biopsy yield defined as the number of patients in whom the results of nodule biopsies performed with the Archimedes® system are consistent with the surgical specimen.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 to 75 years with a suspicious nodule of malignancy (primary lung tumor or metastasis of another solid tumor whose largest diameter is greater than or equal to 8 mm): * Not associated with endobronchial tumor visible during inspection of tracheobronchial tree with soft bronchoscope * Located in any part of the lung more than 10mm from the pleura * For which surgical management (atypical resection, lobectomy, bilobectomy or pneumonectomy) is planned after presentation of the file at a multidisciplinary consultation meeting on thoracic oncology of the Investigating Hospital Center * Patient able to understand the course of the study and giving informed consent * Affiliate or beneficiary of a social security scheme Exclusion Criteria: * Threatening cardiac arrhythmias defined by a rhythm disorder dating discovered less than a month ago * Myocardial infarction less than one month old * Hypercapnic respiratory decompensation less than one month old * coagulopathy * Thrombocytopenia with platelet count \<100,000 / mm3 * Antecedent (ATCD) of significant bleeding during previous bronchoscopy * ATCD of pulmonary arterial hypertension (PAH) or suspicion of PAH defined by a measurement of systolic pulmonary arterial pressure greater than 50 mmHg on echocardiography (this examination is not systematic but the suspicion of PAH on the thoracic CT scan leads to other cardiac echocardiographic examinations or right heart catheterization in case of inconclusive ultrasound) * ATCD of pneumonectomy * Giant bubble\> 5cm located near the nodule or the tunneling path * Inability to stop anticoagulant or antiplatelet therapy before the procedure (taking acetylsalicylic acid at any dose is allowed) * Pregnant or lactating woman * ATCD for thoracic radiotherapy on the nodule side * Patient under tutorship or curatorship
References
Publications (0)
Data not yet available
No reference posted for this study.