Trial Outcomes & Findings for Robotic Bronchoscopy for Peripheral Pulmonary Lesions (NCT NCT03727425)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

24-84 hours post-procedure

Results posted on

2020-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic Assisted Bronchoscopy Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic Assisted Bronchoscopy n=55 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Age, Continuous	67.1 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	42 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	11 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-84 hours post-procedure

Population: 54 patients underwent the robotic bronchoscopy 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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=54 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Number of Participants With Device or Procedure Related Adverse Events	2 Participants

PRIMARY outcome

Timeframe: During the procedure, approximately 1 hour

Population: Radial probe endobronchial ultrasound was available in 53/54 cases.

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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=53 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Successful Navigation to Targeted Peripheral Pulmonary Lesions	51 Participants

SECONDARY outcome

Timeframe: 24-84 hours post-procedure

Population: 54 patients underwent the robotic bronchoscopy 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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=54 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Incidence of Complications Unrelated to Device	0 Participants

SECONDARY outcome

Timeframe: During the procedure, approximately 1 hour

Population: Radial probe endobronchial ultrasound was available in 53/54 cases.

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

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=53 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Time to R-EBUS Confirmation (Lesion Localization)	13 Minutes Interval 25.0 to 75.0

SECONDARY outcome

Timeframe: During the procedure

Population: 54 patients underwent the robotic bronchoscopy procedure

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

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=54 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Total Procedure Time	51 Minutes Interval 25.0 to 75.0

SECONDARY outcome

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

Population: 54 patients underwent the robotic bronchoscopy procedure

Determined from the results of the bronchoscopy.

Outcome measures

Outcome measures
Measure	Robotic Assisted Bronchoscopy n=54 Participants Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Diagnostic Yield	40 Participants

Adverse Events

Robotic Assisted Bronchoscopy

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robotic Assisted Bronchoscopy n=55 participants at risk Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.6% 2/55 • Number of events 2 • Adverse event data was collected from time of procedure through 84 hours post procedure.

Other adverse events

Adverse event data not reported

Additional Information

Scott Rehage

Auris Health, Inc.

Phone: 9256832590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place