CompletedNot applicableNCT03727425
Official study title

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Study summary

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

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Key things to know

Main goalOther

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 forLung; Node

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 14, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?5 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
Other
Study type
Interventional
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. Capable and willing to give informed consent 2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure 3. Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure 4. Lack bleeding disorders

Reasons someone may not be able to joinExclusion criteria

1. Medical contraindication to bronchoscopy 2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT 3. Patients with endobronchial involvement seen on chest CT 4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure 5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study 6. Uncontrolled or irreversible coagulopathy 7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test 8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

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

  • Henry Ford Health SystemDetroit, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • Cleveland ClinicCleveland, Ohio
  • Medical University of South CarolinaCharleston, South Carolina
  • Innova Fairfax HospitalFalls Church, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 14, 2020. Always confirm current availability with the study team.

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