Lung CancerNCT03497026
Auris Robotic Endoscopy System for Bronchoscopy
A study testing Robotic Bronchoscopy Platform in people with Lung Cancer, run by Auris Health, Inc. at 2 sites in United States.
Trial summary
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Robotic Bronchoscopy Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2018to 10 Jul 2018
- 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
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy
Who cannot join
- Medical contraindication to bronchoscopy;
- Ground glass opacity lesions on pre-procedure CT
- Participation in any other clinical trial 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;
- CT scan done over a month before the bronchoscopy procedure.
- Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
El Camino Hospital
Mountain View, California, 94040
Palo Alto Medical Foundation Mountain View Center
Mountain View, California, 94040
About this study
Official title: A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.
Read the detailed description
The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success.
In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.
- Conditions
- Lung Cancer
- Being tested
- Robotic Bronchoscopy Platform
- 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 Bronchoscopy PlatformDevice
Also called The Monarch Platform
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Bronchoscopy | Experimental | Robotic bronchoscopy with Robotic Bronchoscopy Platform Receives: Device: Robotic Bronchoscopy Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
Measured: During the procedure, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start30 Mar 2018
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Why it stopped: Mutual Termination
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.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ganesh Krishna, MD, Principal investigator, El Camino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497026
- Sponsor's protocol ID
- DD082015
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2018
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
- ClinicalTrials.gov ID
- NCT03497026
- Acronym / sponsor ID
- DD082015
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mutual Termination
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Auris Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Posted 15 Nov 2021
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 performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.
Detailed description
The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success.
In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Bronchoscopy | Experimental | Device: Robotic Bronchoscopy PlatformRobotic bronchoscopy with Robotic Bronchoscopy 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)
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy
Key exclusion criteria (7 listed)
- Medical contraindication to bronchoscopy;
- Ground glass opacity lesions on pre-procedure CT
- Participation in any other clinical trial 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;
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 Bronchoscopy PlatformAlso: The Monarch PlatformEligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules. | Device | Robotic Bronchoscopy |
Primary outcome
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
Time frame: During the procedure, up to 2 hours
Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ganesh Krishna, MD principal investigator
El Camino Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Bronchoscopy Platform in people with Lung Cancer, run by Auris Health, Inc. at 2 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 7 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: stopped early, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 15 Nov 2021). 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 Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform (time frame: During the procedure, up to 2 hours). 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 15 Nov 2021.