MedDataX Logo

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

NCT ID: NCT03727425

Last Updated: 2020-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung; Node

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bronchoscopy Robotic bronchoscopy Lung cancer Peripheral lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic assisted bronchoscopy

Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Group Type EXPERIMENTAL

Robotic assisted bronchoscopy

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic assisted bronchoscopy

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Monarch platform

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Exclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Auris Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Gerard A Silvestri, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Thomas R Gildea, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Amit K Mahajan, MD

Role: PRINCIPAL_INVESTIGATOR

Innova Fairfax Hospital

Michael J Simoff, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Innova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Chen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19.

Reference Type DERIVED
PMID: 32822675 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-BR-0001

Identifier Type: -

Identifier Source: org_study_id