Study Stopped
Mutual Termination
Auris Robotic Endoscopy System for Bronchoscopy
A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
1 other identifier
interventional
4
1 country
2
Brief Summary
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Mar 2018
Shorter than P25 for not_applicable lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedResults Posted
Study results publicly available
November 15, 2021
CompletedNovember 15, 2021
September 1, 2021
3 months
April 6, 2018
September 22, 2021
October 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform
Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools.
During the procedure, up to 2 hours
Study Arms (1)
Robotic Bronchoscopy
EXPERIMENTALRobotic bronchoscopy with Robotic Bronchoscopy Platform
Interventions
Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
Eligibility Criteria
You may qualify if:
- to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy
You may not qualify if:
- Medical contraindication to bronchoscopy;
- Ground glass opacity lesions on pre-procedure CT
- Participation in any other clinical trial 30 days before and throughout the duration of the study;
- Uncontrolled or irreversible coagulopathy;
- Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
- CT scan done over a month before the bronchoscopy procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
El Camino Hospital
Mountain View, California, 94040, United States
Palo Alto Medical Foundation Mountain View Center
Mountain View, California, 94040, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Rehage
- Organization
- Auris Health
Study Officials
- PRINCIPAL INVESTIGATOR
Ganesh Krishna, MD
El Camino Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
April 6, 2018
First Posted
April 13, 2018
Study Start
March 30, 2018
Primary Completion
July 10, 2018
Study Completion
July 10, 2018
Last Updated
November 15, 2021
Results First Posted
November 15, 2021
Record last verified: 2021-09