N/A N=55 Other

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Lung; Node

Bottom Line

View on ClinicalTrials.gov: NCT03727425 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Dec 2020

Primary outcome: Primary: Number of Participants With Device or Procedure Related Adverse Events — 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robotic assisted bronchoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Auris Health, Inc.
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Device or Procedure Related Adverse Events	2	—
PRIMARY Successful Navigation to Targeted Peripheral Pulmonary Lesions	51	—
SECONDARY Incidence of Complications Unrelated to Device	—	—
SECONDARY Time to R-EBUS Confirmation (Lesion Localization)	13	—
SECONDARY Total Procedure Time	51	—
SECONDARY Diagnostic Yield	40	—

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.

Eligibility Criteria

Inclusion Criteria

Capable and willing to give informed consent
Acceptable candidate for an elective, non-emergent bronchoscopic procedure
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
Lack bleeding disorders

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03727425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.