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NCT04182815 · ClinicalTrials.gov registry record
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung
A clinical trial of Lung Cancer and Pulmonary Nodule, sponsored by Auris Health.
- Completed
- Registry status
- 691
- Enrollment target
- 19
- Study locations
NCT04182815: Completed study of Lung Cancer and Pulmonary Nodule, sponsored by Auris Health.
NCT04182815 is a study of Lung Cancer and Pulmonary Nodule that has completed, run by Auris Health. The registered enrollment target is 691 participants, below the 934-participant average among 409 other Lung Cancer trials with a reported enrollment target (26% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04182815, a study of Lung Cancer and Pulmonary Nodule, has completed, sponsored by Auris Health.
- COMPLETED
- Registry status
- 691 participants
- Enrollment target
- 19
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Robotic assisted bronchoscopy
Study Locations (19)
California
- Costal Pulmonary Associates - Encinitas
- Eisenhower Medical Center - Rancho Mirage
Illinois
- University of Chicago Medicine - Chicago
- Northwestern Medicine Central DuPage Hospital - Winfield
Pennsylvania
- Clinical Research Associates of Central PA - Altoona
- University of Pittsburgh Medical Center, Hamot - Erie
Arizona
- Mayo Clinic Arizona - Scottsdale
Connecticut
- The University of Connecticut Health Center - Farmington
Florida
- Sarasota Memorial Hospital - Sarasota
Indiana
- Franciscan Health Indianapolis - Indianapolis
Michigan
- Spectrum Health System - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2019-12-10 |
| Est. Completion | 2023-12-15 |
What the finished NCT04182815 record still lists
NCT04182815 is an observational study that tracks outcomes without assigning an intervention. The registered 691 participants enrollment target is mid-sized for trials with a published cap, below the 934-participant average among 409 other Lung Cancer trials with a reported enrollment target (26% lower).
The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Robotic assisted bronchoscopy is the first listed.
NCT04182815 lists 19 locations in 16 states (California, Illinois, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04182815 about?
NCT04182815 is a clinical study titled "Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung". 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.
What is the current status of trial NCT04182815?
This trial is currently completed. The enrollment target is 691 participants. The study started on 2019-12-10. Estimated completion is 2023-12-15.
What conditions does trial NCT04182815 study?
This clinical trial studies the following conditions: Lung Cancer, Pulmonary Nodule.
What interventions are being tested in trial NCT04182815?
The interventions under investigation include: Robotic assisted bronchoscopy (DEVICE).
Who is sponsoring clinical trial NCT04182815?
This trial is sponsored by Auris Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04182815 being conducted?
This trial has 19 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04182815's enrollment target sits among peer trials
691 61st of 409 higher than 349 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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