Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Sponsors

Lead sponsor: Auris Health, Inc.

Source Auris Health, Inc.
Brief Summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Detailed Description

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, 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. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Overall Status Recruiting
Start Date December 10, 2019
Completion Date December 2023
Primary Completion Date December 2023
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of device or procedure related complications up to 7 days post procedure
Secondary Outcome
Measure Time Frame
Rate of device or procedure related complications up to 7 days post procedure
Rate of all pneumothoraxes up to 7 days post procedure
Total procedure time During the procedure
Rate of conversion to conventional bronchoscopic procedure During the procedure
Rate of adverse events unrelated to device or procedure up to 7 days post procedure
Stage at diagnosis up to 24 months post procedure
Diagnostic yield up to 24 months post procedure
Sensitivity for malignancy up to 24 months post procedure
Specificity up to 24 months post procedure
Positive predictive value up to 24 months post procedure
Negative predictive value up to 24 months post procedure
Rate of post-bronchoscopy infections up to 7 days post-procedure
Enrollment 1200
Condition
Intervention

Intervention type: Device

Intervention name: Robotic assisted bronchoscopy

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

Arm group label: Robotic assisted bronchoscopy

Other name: Robotic assisted bronchoscopy with Monarch platform

Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

1. Over 21 years of age;

2. Capable and willing to give informed consent;

3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;

4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 14 days of the intended bronchoscopy

Exclusion Criteria:

1. Medical contraindication to bronchoscopy as assessed by the investigator

2. Presence of uncorrectable bleeding disorders

3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker

4. Patients with the target lesion having endobronchial involvement seen on chest CT

5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,

6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;

7. Uncontrolled or irreversible coagulopathy;

8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;

9. CT scan done greater than 14 days before the bronchoscopy procedure.

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Septimiu Murgu, MD Principal Investigator University of Chicago
Overall Contact

Last name: Scott Rehage

Phone: 6508370301

Phone ext: 6508370301

Email: [email protected]

Location
facility status contact investigator
Sarasota Memorial Hospital Not yet recruiting Mary Bradley Paul Chomiak, MD Principal Investigator
University of Chicago Medicine Recruiting Candace Murphy Septimiu Murgu, MD Principal Investigator
Minnesota Lung Center, Ltd Recruiting Buffi Moss Jonathan T Hovda, MD Principal Investigator
Cancer Treatment Centers of America Recruiting Faye Biggs Daniel Nader, DO Principal Investigator
Clinical Research Associates of Central PA Recruiting Shari Edevane Sandeep Bansal, MD Principal Investigator
University of Pittsburgh Medical Center, Hamot Recruiting Patty Henry Christopher Lau, MD Principal Investigator
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Robotic assisted bronchoscopy

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

Acronym TARGET
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov