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Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2 | Clinical Trials | Clareo Health

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Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

NCT02867371•Broncus Medical Inc

Summary

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 21-75 years at screening
•2. Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension
•3. No known endobronchial tumor
•4. Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE.
•5. Willing to participate in all aspects of study protocol for duration of study
•6. Able to understand study requirements
•7. Subject or legally authorized representative signs study-related informed consent document

Exclusion Criteria

•1. Any contraindication to bronchoscopy, for example:
•1. Untreatable life-threatening arrhythmias
•2. Inability to adequately oxygenate the patient during the procedure
•3. Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
•4. Recent myocardial infarction
•5. Previously diagnosed high-grade tracheal obstruction
•6. Uncorrectable coagulopathy
•2. Known coagulopathy
•3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
•4. History of major bleeding with bronchoscopy
+18 more criteria

Locations (10)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Tulsa, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Houston Methodist Hospital

Houston, Texas, United States

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

ThoraxKlinik

Heidelberg, Germany

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

August 1, 2016

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2018

Last Updated

November 1, 2019

Enrollment

166

ACTUAL participants

Conditions

Lung Cancer

Interventions

Archimedes System

DEVICE

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Magnetic Resonance Imaging of the Lung: Oncological Applications

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial