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Completed

NCT Number: NCT03727425

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

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 information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System, Detroit, Michigan, United States

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About this study

Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic assisted bronchoscopy

Device

Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Other names: Monarch platform

Primary outcomes

  1. Number of Participants With Device or Procedure Related Adverse Events

    Time frame: 24-84 hours post-procedure

    Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

  2. Successful Navigation to Targeted Peripheral Pulmonary Lesions

    Time frame: During the procedure, approximately 1 hour

    Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.

Secondary outcomes

  1. Incidence of Complications Unrelated to Device

    Time frame: 24-84 hours post-procedure

    Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.

  2. Time to R-EBUS Confirmation (Lesion Localization)

    Time frame: During the procedure, approximately 1 hour

    Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.

  3. Total Procedure Time

    Time frame: During the procedure

    Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.

  4. Diagnostic Yield

    Time frame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.

    Determined from the results of the bronchoscopy.

Sponsors and collaborators

Lead sponsor

Auris Health, Inc.

Industry

Registry information

Official study title

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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