Trial Outcomes & Findings for Auris Robotic Endoscopy System for Bronchoscopy (NCT NCT03497026)

Results Overview

Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

During the procedure, up to 2 hours

Results posted on

2021-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic Bronchoscopy Robotic bronchoscopy with Robotic Bronchoscopy Platform Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic Bronchoscopy n=4 Participants Robotic bronchoscopy with Robotic Bronchoscopy Platform Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=4 Participants
Region of Enrollment United States	4 participants n=4 Participants

PRIMARY outcome

Timeframe: During the procedure, up to 2 hours

Population: due to termination after 4 subjects enrolled, no statistical analyses would have been performed or would be considered scientifically appropriate.

Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.

Outcome measures

Outcome measures
Measure	Robotic Bronchoscopy n=4 Participants Robotic bronchoscopy with Robotic Bronchoscopy Platform Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform	4 Participants

Adverse Events

Robotic Bronchoscopy

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robotic Bronchoscopy n=4 participants at risk Robotic bronchoscopy with Robotic Bronchoscopy Platform Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Respiratory, thoracic and mediastinal disorders hospital admission for planned surgery	50.0% 2/4 • Number of events 2 • from enrollment through patient follow-up; 6 weeks

Other adverse events

Other adverse events
Measure	Robotic Bronchoscopy n=4 participants at risk Robotic bronchoscopy with Robotic Bronchoscopy Platform Robotic Bronchoscopy Platform: Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Respiratory, thoracic and mediastinal disorders coughing	100.0% 4/4 • Number of events 4 • from enrollment through patient follow-up; 6 weeks
Respiratory, thoracic and mediastinal disorders sore throat	75.0% 3/4 • Number of events 4 • from enrollment through patient follow-up; 6 weeks
Respiratory, thoracic and mediastinal disorders wheezing	50.0% 2/4 • Number of events 2 • from enrollment through patient follow-up; 6 weeks

Additional Information

Scott Rehage

Auris Health

Phone: 925 6832590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study mutually terminated, no data analyzed
Publication restrictions are in place

Restriction type: OTHER