Evaluation of the Archimedes™ System for Transparenchymal Nodule Access

NCT02460120 | Terminated

• 1 other identifier: Protocol 43
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of biopsies yielding tissue sufficient for diagnosis

  The the number of nodules with at least one biopsy sufficient for a definitive tissue diagnosis divided by the number of nodules sampled by the Archimedes System.

  Up to 1 year

Secondary Outcomes (4)

• Procedure planning time

  Up to 1 year

• Nodule access time

  Up to 1 year

• Fluoroscopy time

  Up to 1 year

• Patient registration time

  Up to 1 year

Study Arms (1)

Navigation and tissue sampling

EXPERIMENTAL

Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System

Device: Archimedes System

Interventions

Archimedes System DEVICE

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs

Navigation and tissue sampling

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-75 years at screening
• Highly suspicious SPN, defined as distinct nodule with a diameter of ≥8mm in its largest dimension
• No known endobronchial tumor
• Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE.
• Willing to participate in all aspects of study protocol for duration of study
• Able to understand study requirements
• Signs study-related informed consent document

You may not qualify if:

• Any contraindication to bronchoscopy, for example:
• Untreatable life-threatening arrhythmias
• Inability to adequately oxygenate the patient during the procedure
• Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
• Recent myocardial infarction
• Previously diagnosed high-grade tracheal obstruction
• Uncorrectable coagulopathy
• Known coagulopathy
• Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
• History of major bleeding with bronchoscopy
• Suspected pulmonary hypertension: additional testing required, such as echocardiogram
• Moderate-to-severe pulmonary fibrosis
• Severe emphysema or COPD: additional testing and PI consent is required
• Bullae \>5 cm located in vicinity of target SPN
• Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:

Sponsors & Collaborators

• Broncus Medical Inc: lead

Study Sites (1)

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Nader, D.O.

  Cancer Treatment Centers of America at Southwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

US (1)