Lung; NodeNCT03727425

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

A study testing Robotic assisted bronchoscopy in people with Lung; Node, run by Auris Health, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lung; Node
What is being tested?: Robotic assisted bronchoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 5 sitesUnited States
Study dates: 1 Nov 2018to 30 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capable and willing to give informed consent
Acceptable candidate for an elective, non-emergent bronchoscopic procedure
Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
Lack bleeding disorders

Who cannot join

Medical contraindication to bronchoscopy
Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
Patients with endobronchial involvement seen on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
Uncontrolled or irreversible coagulopathy
Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
Innova Fairfax Hospital
Falls Church, Virginia, 22042
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Read the detailed description

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. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Conditions: Lung; Node
Being tested: Robotic assisted bronchoscopy
Keywords: Bronchoscopy, Robotic bronchoscopy, Lung cancer, Peripheral lesions
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 Monarch platform
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Study groups in NCT03727425
Study group	Role	What they receive
Robotic assisted bronchoscopy	Experimental	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.

Number of Participants With Device or Procedure Related Adverse Events
Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Measured: 24-84 hours post-procedure
Successful Navigation to Targeted Peripheral Pulmonary Lesions
Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.
Measured: During the procedure, approximately 1 hour

Secondary outcomes (4)

Incidence of Complications Unrelated to Device
Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.
Measured: 24-84 hours post-procedure
Time to R-EBUS Confirmation (Lesion Localization)
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
Measured: During the procedure, approximately 1 hour
Total Procedure Time
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
Measured: During the procedure
Diagnostic Yield
Determined from the results of the bronchoscopy.
Measured: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201830 Jun 2020

First posted1 Nov 2018
Study start1 Nov 2018
Primary completion12 Sep 2019
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung; NodeStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03727425
Sponsor's protocol ID: 18-BR-0001
Status last verified: Oct 2020
First submitted: 24 Oct 2018
Last updated: 14 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19.
PubMed 32822675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung; Node trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study
ClinicalTrials.gov ID: NCT03727425
Acronym / sponsor ID: 18-BR-0001
Conditions: Lung; Node
Keywords: Bronchoscopy, Robotic bronchoscopy, Lung cancer, Peripheral lesions
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Auris Health, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2018 (actual)
Primary completion: 12 Sep 2019 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 1 Nov 2018 (actual)
Results: Posted 14 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Robotic assisted bronchoscopy	Experimental	Device: Robotic assisted bronchoscopyRobotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Capable and willing to give informed consent
Acceptable candidate for an elective, non-emergent bronchoscopic procedure
Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
Lack bleeding disorders

Key exclusion criteria (8 listed)

Medical contraindication to bronchoscopy
Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
Patients with endobronchial involvement seen on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study

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: Monarch platformRobotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.	Device	Robotic assisted bronchoscopy

Primary outcome

Number of Participants With Device or Procedure Related Adverse Events
Time frame: 24-84 hours post-procedure
Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Successful Navigation to Targeted Peripheral Pulmonary Lesions
Time frame: During the procedure, approximately 1 hour
Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.

4 secondary outcomes

Incidence of Complications Unrelated to Device
Time frame: 24-84 hours post-procedure
Time to R-EBUS Confirmation (Lesion Localization)
Time frame: During the procedure, approximately 1 hour
Total Procedure Time
Time frame: During the procedure
Diagnostic Yield
Time frame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.

Results and safety

Results posted to the registry on 14 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robotic Assisted Bronchoscopy	55	55

Primary outcome: Number of Participants With Device or Procedure Related Adverse Events

Time frame: 24-84 hours post-procedure. Count of participants. Unit: Participants

Measure	Robotic Assisted Bronchoscopy n = 54
Value	2

Population analysed: 54 patients underwent the robotic bronchoscopy procedure

Primary outcome: Successful Navigation to Targeted Peripheral Pulmonary Lesions

Time frame: During the procedure, approximately 1 hour. Count of participants. Unit: Participants

Measure	Robotic Assisted Bronchoscopy n = 53
Value	51

Population analysed: Radial probe endobronchial ultrasound was available in 53/54 cases.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from time of procedure through 84 hours post procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robotic Assisted Bronchoscopy	2 of 55 (3.6%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32822675Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19.
Individual participant dataSharing planned: No

Related trials for Lung; Node

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RecruitingPhase 2
A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
Lung Non-Small Cell Carcinoma
RecruitingPhase 2
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features
Non-small Cell Lung Cancer Stage III
RecruitingObservational study
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RecruitingObservational study
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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.

Alexander Chen, MD principal investigator

Washington University School of Medicine

Gerard A Silvestri, MD principal investigator

Medical University of South Carolina

Thomas R Gildea, MD principal investigator

The Cleveland Clinic

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robotic assisted bronchoscopy in people with Lung; Node, run by Auris Health, Inc. at 5 sites in United States.

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 8 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 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Device or Procedure Related Adverse Events (time frame: 24-84 hours post-procedure). The study lists 2 primary outcomes in all. 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 NCT03727425, which also lists 1 linked publication.

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 14 Dec 2020.