CompletedNot applicableNCT04182815
Official study title

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedRobotic assisted bronchoscopy

The study team can explain what participation involves.

Who it may be forPulmonary Nodule · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 28, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Auris Health, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Auris Health, Inc.
Interventions being studied
Device: Robotic assisted bronchoscopy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Over 21 years of age; 2. Capable and willing to give informed consent; 3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure; 4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

Reasons someone may not be able to joinExclusion criteria

1. Medical contraindication to bronchoscopy as assessed by the investigator 2. Presence of uncorrectable bleeding disorders 3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker 4. Patients with the target lesion having endobronchial involvement seen on chest CT 5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, 6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study; 7. Uncontrolled or irreversible coagulopathy; 8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure; 9. CT scan done greater than 28 days before the bronchoscopy procedure.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic ArizonaScottsdale, Arizona
  • Costal Pulmonary AssociatesEncinitas, California
  • Eisenhower Medical CenterRancho Mirage, California
  • The University of Connecticut Health CenterFarmington, Connecticut
  • Sarasota Memorial HospitalSarasota, Florida
  • University of Chicago MedicineChicago, Illinois
  • Northwestern Medicine Central DuPage HospitalWinfield, Illinois
  • Franciscan Health IndianapolisIndianapolis, Indiana
  • Spectrum Health SystemGrand Rapids, Michigan
  • Minnesota Lung Center, LtdMinneapolis, Minnesota
  • Roswell Park Cancer InstituteBuffalo, New York
  • Cleveland ClinicCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 28, 2025. Always confirm current availability with the study team.

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