NCT02867371

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2016

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

August 11, 2016

Last Update Submit

October 30, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of biopsies yielding tissue sufficient for diagnosis

    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 SystemDEVICE

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

-Navigation and tissue sampling

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-75 years at screening
  • Highly suspicious pulmonary nodule(s), 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
  • Subject or legally authorized representative 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 nodule or tunnel
  • Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

ThoraxKlinik

Heidelberg, Germany

Location

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

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

August 11, 2016

First Posted

August 15, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

HK(1)CN(2)US(6)DE(1)