A Study of Robot-Assisted Bronchoscopy in Chinese Participants With Lung Lesions

NCT05426213 | Withdrawn FDA Device

• 1 other identifier: EDS202101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Navigation Success Rate

  Navigation success rate is defined as the percentage of successful navigation to the targeted lung lesion (lesion localization) as confirmed by radial probe endobronchial ultrasound (R-EBUS) imaging through Monarch Platform during bronchoscopy procedure.

  Intraoperative

Secondary Outcomes (7)

• Time to R-EBUS Confirmation

  Intraoperative

• Time to the Tissue Acquisition

  Intraoperative

• Total Procedure Time

  Intraoperative

• Number of Conversion to Conventional Bronchoscopic Procedure

  Intraoperative

• Number of Participants with Pneumothorax Requiring Intervention

  Up to 7 days post procedure

Study Arms (1)

Robot-assisted Bronchoscopy

OTHER

Participants with 8-50 millimeters (mm) diameter size lung lesions identified on computed tomography (CT) scan will be enrolled for robotic assisted bronchoscopy (Monarch Platform) biopsy procedure.

Device: Robot-assisted Bronchoscopy (Monarch Platform)

Interventions

Robot-assisted Bronchoscopy (Monarch Platform) DEVICE

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

Robot-assisted Bronchoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable and willing to give informed consent
• Acceptable candidate for an elective, non-emergency bronchoscopic procedure
• Lung lesions suspected of malignancy, between 8-50 millimeters (mm) in diameter size identified on thin slice (0.9-1.25 mm) computed tomography (CT) scan within 14 days, requiring bronchoscopic biopsy for diagnosis
• No more than 1 lung lesion will be targeted for robot-assisted bronchoscopy biopsy

You may not qualify if:

• Pre-Operative
• Participants with pure ground-glass opacity lesions on pre-procedure chest CT
• Participants with the target lesion having endobronchial involvement seen on chest CT
• Medical contraindications to bronchoscopy and/or anesthesia as assessed by the investigator (such as severe cardiac arrhythmias, severe hypertension, severe cardiopulmonary dysfunction, myocardial infarction, unstable angina pectoris et cetera \[etc\]) precluding safe bronchoscopic procedure

Sponsors & Collaborators

• Auris Health, Inc.: lead

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Auris Health, Inc. Clinical Trial

  Auris Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 21, 2022
• Study Start: July 12, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share