An interventional study of Robotic Bronchoscopy Platform in Lung Cancer, sponsored by Auris Health, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Auris Health, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Diagnostic
Among 12 studies in Lung Neoplasms by Johnson & Johnson — none open to participants now, none under way, none of them phase 3. Lung Neoplasms · Johnson & Johnson.
Among the 12 studies in Lung Neoplasms by Johnson & Johnson, this one is the 8th largest by enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2018, is one of 8 with no phase, and was the 3rd registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
Browse Lung Neoplasms studies →None of the 12 studies in Lung Neoplasms by Johnson & Johnson is open now. The open studies under Lung Neoplasms, anywhere →
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2018.
This study's enrollment of 4 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Median enrollment 13 across the 10 interventional studies, 491 across the 2 observational. Of the 10 that completed or were terminated, 5 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Auris Health, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Auris Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Lung Neoplasms by Johnson & Johnson, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Robotic bronchoscopy with Robotic Bronchoscopy Platform
Device: Robotic Bronchoscopy Platform
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Also known as: The Monarch Platform
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.
Time frame: During the procedure, up to 2 hours
| Milestone | Robotic Bronchoscopy |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
| Participants | Robotic Bronchoscopy |
|---|---|
| Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform | 4 |
Collected over from enrollment through patient follow-up; 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic Bronchoscopy | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Event | Robotic Bronchoscopy |
|---|---|
| hospital admission for planned surgeryRespiratory, thoracic and mediastinal disorders | 2/4 |
| Event | Robotic Bronchoscopy |
|---|---|
| coughingRespiratory, thoracic and mediastinal disorders | 4/4 |
| sore throatRespiratory, thoracic and mediastinal disorders | 3/4 |
| wheezingRespiratory, thoracic and mediastinal disorders | 2/4 |
| Age, Categorical(Participants) | Robotic Bronchoscopy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Robotic Bronchoscopy |
|---|---|
| Female | 3 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | Robotic Bronchoscopy |
|---|
| Region of Enrollment(participants) | Robotic Bronchoscopy |
|---|---|
| United States | 4 |
Ran from Mar 2018 to primary completion in Jul 2018, 3 months.
Results were first posted in Nov 2021, 3 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.