Pulmonary NoduleTARGETNCT04182815
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
An observational study of Pulmonary Nodule and Lung Cancer, run by Auris Health, Inc. at 19 sites in 3 countries.
Trial summary
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Nodule, Lung Cancer
- What is being tested?
- Robotic assisted bronchoscopy
- Type of treatment
- Medical device
- How many people
- 691 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 10 Dec 2019to 15 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.
Who may be able to join
- Over 21 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy
Who cannot join
- Medical contraindication to bronchoscopy as assessed by the investigator
- Presence of uncorrectable bleeding disorders
- Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
- Patients with the target lesion having endobronchial involvement seen on chest CT
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
- Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
Show all 9Show fewer
- Uncontrolled or irreversible coagulopathy;
- Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
- CT scan done greater than 28 days before the bronchoscopy procedure.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States17 sites
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16602
Roswell Park Cancer Institute
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 931531
Costal Pulmonary Associates
Encinitas, California, 92024
University of Pittsburgh Medical Center, Hamot
Erie, Pennsylvania, 16550
The University of Connecticut Health Center
Farmington, Connecticut, 06030
Spectrum Health System
Grand Rapids, Michigan, 49546
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Minnesota Lung Center, Ltd
Minneapolis, Minnesota, 55407
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Eisenhower Medical Center
Rancho Mirage, California, 92270
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
About this study
Official title: Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.
Read the detailed description
Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.
A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.
- Conditions
- Pulmonary Nodule, Lung Cancer
- Being tested
- Robotic assisted bronchoscopy
- Keywords
- Bronchoscopy, Robotic bronchoscopy, Lung Lesions, Peripheral lesions, Lung Cancer, Monarch
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted bronchoscopyDevice
Also called Robotic assisted bronchoscopy with Monarch platform
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted bronchoscopy | Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Receives: Device: Robotic assisted bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device or procedure related complications
The primary endpoint is a composite that includes pneumothorax requiring intervention rated as > Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as > Grade 1 according to the CTCAE scale, and respiratory failure, rated as > Grade 3 according to the CTCAE scale.
Measured: up to 7 days post procedure
Secondary outcomes (9)
Rate of device or procedure related complications
Individual components of the primary endpoint
Measured: up to 7 days post procedure
Rate of all pneumothoraxes
Measured: up to 7 days post procedure
Total procedure time
Measured: During the procedure
Rate of conversion to conventional bronchoscopic procedure
Measured: During the procedure
Rate of adverse events unrelated to device or procedure
Measured: up to 7 days post procedure
Stage at diagnosis
Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer
Measured: up to 24 months post procedure
Diagnostic yield
Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples
Measured: up to 24 months post procedure
Sensitivity for malignancy
Measured: up to 24 months post procedure
Rate of post-bronchoscopy infections
Measured: up to 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start10 Dec 2019
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Septimiu Murgu, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182815
- Sponsor's protocol ID
- 19-BR-0001
- Acronym
- TARGET
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gomes C, Cowan B, Xiao M, Morris P, Pederson D, Yasufuku K. Diagnostic effectiveness and safety of robotic-assisted bronchoscopy for subsolid pulmonary nodules: A multicenter prospective observational study. J Thorac Cardiovasc Surg. 2025 Oct;170(4):945-954. doi: 10.1016/j.jtcvs.2025.05.021. Epub 2025 Jun 7.
PubMed 40490212Murgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA; TARGET Investigators. A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes With Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial. Chest. 2025 Aug;168(2):539-555. doi: 10.1016/j.chest.2025.04.022. Epub 2025 Apr 27.
PubMed 40300665Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
- ClinicalTrials.gov ID
- NCT04182815
- Acronym / sponsor ID
- TARGET / 19-BR-0001
- Conditions
- Pulmonary Nodule, Lung Cancer
- Keywords
- Bronchoscopy, Robotic bronchoscopy, Lung Lesions, Peripheral lesions, Lung Cancer, Monarch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Auris Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 2 Dec 2019 (actual)
- 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.
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.
Detailed description
Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.
A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted bronchoscopy | – | Device: Robotic assisted bronchoscopyRobotic assisted bronchoscopy procedures will be performed using the Monarch platform. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indeterminate pulmonary nodules considered to undergo a bronchoscopy procedure per standard of care.
Key inclusion criteria (4 listed)
- Over 21 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy
Key exclusion criteria (9 listed)
- Medical contraindication to bronchoscopy as assessed by the investigator
- Presence of uncorrectable bleeding disorders
- Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
- Patients with the target lesion having endobronchial involvement seen on chest CT
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
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 |
|---|---|---|
| Robotic assisted bronchoscopyAlso: Robotic assisted bronchoscopy with Monarch platformRobotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. | Device | Robotic assisted bronchoscopy |
Primary outcome
Incidence of device or procedure related complications
Time frame: up to 7 days post procedure
The primary endpoint is a composite that includes pneumothorax requiring intervention rated as > Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as > Grade 1 according to the CTCAE scale, and respiratory failure, rated as > Grade 3 according to the CTCAE scale.
9 secondary outcomes
Rate of device or procedure related complications
Time frame: up to 7 days post procedure
Rate of all pneumothoraxes
Time frame: up to 7 days post procedure
Total procedure time
Time frame: During the procedure
Rate of conversion to conventional bronchoscopic procedure
Time frame: During the procedure
Rate of adverse events unrelated to device or procedure
Time frame: up to 7 days post procedure
Stage at diagnosis
Time frame: up to 24 months post procedure
Diagnostic yield
Time frame: up to 24 months post procedure
Sensitivity for malignancy
Time frame: up to 24 months post procedure
Rate of post-bronchoscopy infections
Time frame: up to 7 days post-procedure
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 28 Feb 2025.
- Derived from this study: PubMed 40490212Gomes C, Cowan B, Xiao M, Morris P, Pederson D, Yasufuku K. Diagnostic effectiveness and safety of robotic-assisted bronchoscopy for subsolid pulmonary nodules: A multicenter prospective observational study. J Thorac Cardiovasc Surg. 2025 Oct;170(4):945-954. doi: 10.1016/j.jtcvs.2025.05.021. Epub 2025 Jun 7.
- Derived from this study: PubMed 40300665Murgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA; TARGET Investigators. A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes With Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial. Chest. 2025 Aug;168(2):539-555. doi: 10.1016/j.chest.2025.04.022. Epub 2025 Apr 27.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- Individual participant dataSharing planned: No
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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.
Septimiu Murgu, MD principal investigator
University of Chicago
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule and Lung Cancer, run by Auris Health, Inc. at 19 sites in 3 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 4 inclusion and 9 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, China. 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?
Incidence of device or procedure related complications (time frame: up to 7 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182815, which also lists 3 linked publications.
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 28 Feb 2025.