An interventional study of Robot-assisted Bronchoscopy (Monarch Platform) in Lung Neoplasms, sponsored by Auris Health, Inc.. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
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 9th largest by enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2022, is one of 8 with no phase, and was the 12th 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 2022.
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.
Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.
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:
Pre-Operative
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 biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Participants with 8-50 millimeters (mm) diameter size lung lesions identified on computed tomography (CT) scan will be enrolled for robotic assisted bronchoscopy (Monarch Platform) biopsy procedure.
Device: Robot-assisted Bronchoscopy (Monarch Platform)
Robotic assisted bronchoscopy biopsy procedures will be performed using the Monarch platform.
Navigation Success Rate
Navigation success rate is defined as the percentage of successful navigation to the targeted lung lesion (lesion localization) as confirmed by radial probe endobronchial ultrasound (R-EBUS) imaging through Monarch Platform during bronchoscopy procedure.
Time frame: Intraoperative
Time to R-EBUS Confirmation
Time to R-EBUS confirmation is defined by the time from the robotic bronchoscope inserted into the oropharynx to the localization of the targeted lesion confirmed by R-EBUS.
Time frame: Intraoperative
Time to the Tissue Acquisition
Time to the tissue acquisition is defined by the time the robotic bronchoscope is inserted into the oropharynx until the tissue acquisition is confirmed by the Rapid On-site evaluation (ROSE).
Time frame: Intraoperative
Total Procedure Time
Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the robotic bronchoscope is removed.
Time frame: Intraoperative
Number of Conversion to Conventional Bronchoscopic Procedure
Number of conversion to conventional bronchoscopic procedure is defined as the number of procedures converted to other diagnostic modality due to inability of the Monarch platform to complete the intended bronchoscopy.
Time frame: Intraoperative
Number of Participants with Pneumothorax Requiring Intervention
Number of participants with pneumothorax requiring intervention (rated as greater than \[\>\] Grade 1 according to the Common Terminology Criteria for Adverse Events \[CTCAE\] scale) will be reported.
Time frame: Up to 7 days post procedure
Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention
Number of participants with device or procedure related bleeding requiring medical intervention (rated as \>Grade 1 according to the CTCAE scale) will be reported.
Time frame: Up to 7 days post procedure
Number of Participants with Device or Procedure Related Respiratory Failure
Number of participants with device or procedure related respiratory failure (rated as \>Grade 3 according to the CTCAE scale) will be reported.
Time frame: Up to 7 days post procedure
No study locations are listed for this record.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Data sharing details ↗ · yoda.yale.edu
Started Jul 2022 (actual). Primary completion is estimated for Sep 2023, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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