Lung CancerEAST2NCT02867371
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
A study testing Archimedes System in people with Lung Cancer, run by Broncus Medical Inc at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Archimedes System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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:
- ASA class > 3
- > stage 3 heart failure
- severe cachexia
- severe respiratory insufficiency or hypoxia
- Ongoing systemic infection
- Contraindication to general anesthesia
- Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
- Participation in any other study in last 30 days
- Prior thoracic surgery on the same side of the lung as the SPN.
- Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
- Life expectancy of less than one year.
- Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
- Prior radiation therapy treatment in the target lobe
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University
Durham, North Carolina, 27710
Houston Methodist Hospital
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
China2 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
About this study
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
- Being tested
- Archimedes System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archimedes SystemDevice
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
| Study group | Role | What they receive |
|---|---|---|
| -Navigation and tissue sampling | Experimental | Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System Receives: Device: Archimedes System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (4)
Procedure planning time
The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported
Measured: Up to 1 year
Nodule access time
The time from the start of navigation until the sheath has been placed at the first biopsy target.
Measured: Up to 1 year
Fluoroscopy time
The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry.
Measured: Up to 1 year
Patient registration time
The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Broncus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867371
- Sponsor's protocol ID
- Protocol 44
- Acronym
- EAST2
- Status last verified
- Oct 2019
- First submitted
- 11 Aug 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
- ClinicalTrials.gov ID
- NCT02867371
- Acronym / sponsor ID
- EAST2 / Protocol 44
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Broncus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| -Navigation and tissue sampling | Experimental | Device: Archimedes SystemGuided bronchoscopic navigation and lung tissue sampling using the Archimedes System |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- Any contraindication to bronchoscopy, for example:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Archimedes SystemThe Archimedes System is an image-guided navigation system used to access tissue samples in the lungs | Device | -Navigation and tissue sampling |
Primary outcome
Proportion of biopsies yielding tissue sufficient for diagnosis
Time frame: Up to 1 year
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.
4 secondary outcomes
Procedure planning time
Time frame: Up to 1 year
Nodule access time
Time frame: Up to 1 year
Fluoroscopy time
Time frame: Up to 1 year
Patient registration time
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Archimedes System in people with Lung Cancer, run by Broncus Medical Inc at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, China, Germany, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of biopsies yielding tissue sufficient for diagnosis (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.