Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Auris Health

Status: Completed

Conditions: Lung; Node

Treatments: Device: Robotic assisted bronchoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03727425

18-BR-0001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

55 participants in 1 patient group

Robotic assisted bronchoscopy

Experimental group

Description:

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

Treatment:

Device: Robotic assisted bronchoscopy