CompletedNot applicableNCT04182815

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.

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

StatusCompleted
PhaseNot applicable
U.S. locations19
SponsorAuris Health, Inc.
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

Inclusion 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 Exclusion 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.

View original record ↗