Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000984695
Ethics application status
Approved
Date submitted
30/08/2014
Date registered
12/09/2014
Date last updated
17/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
System to assist with the diagnosis of suspected lung cancer in patients
Scientific title
A Non-randomized Study to Evaluate the Safety and Performance of the Auris Endoscopy System in patients suspected with lung cancer
Secondary ID [1] 285264 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 292913 0
Condition category
Condition code
Cancer 293199 293199 0 0
Lung - Non small cell
Cancer 293200 293200 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Auris bronchoscopic system guides bronchoscopic tools within the airways to enable biopsy of specimens from suspected malignant lesions using automated mechanical user controls.

The patients will be selected based on the need for a lung biopsy procedure for suspected malignant lesions. A biopsy procedure will be required for this patient regardless of the technique to be used. These techniques can vary from a bronchoscopic approach to a transthoracic (through the chest wall) needle approach.

Most often the patient will only need one procedure to evaluate the tissue obtained through the biopsy.
Intervention code [1] 290143 0
Treatment: Devices
Intervention code [2] 290222 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293069 0
The primary endpoint of the study is the safety profile of the system which will include the incidence of complications and adverse events. Primary adverse events associated with a bronchoscopic biopsy are pneumothorax and bleeding. Pneumothorax is when air enters into the thoracic cavity and results in the lung collapsing. The patient will feel a sense of breathlessness due to the pneumothorax. Bleeding can be seen during the procedure if it occurs during the bronchoscopic procedure. Hemoptysis or coughing up blood is another indication of bleeding from the biopsy site.
Timepoint [1] 293069 0
48 hours post procedure
Secondary outcome [1] 310286 0
The secondary endpoint is the completion of the intended bronchoscopic procedure and confirmation of correct location via pathology evaluation of resected tissue.
Timepoint [1] 310286 0
Post procedure pathological evaluation

Eligibility
Key inclusion criteria
Subject age above 18 yr of age

Signed informed consent provided

A negative pregnancy test in a woman with child-bearing potential

Lesions in the central airways or peripheral lesions with bronchus sign suspected of malignancy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical contraindication to bronchoscopy

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.

Inability to give consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2014
Actual
12/09/2014
Date of last participant enrolment
Anticipated
Actual
26/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 6328 0
Costa Rica
State/province [1] 6328 0
San Jose

Funding & Sponsors
Funding source category [1] 289884 0
Commercial sector/Industry
Name [1] 289884 0
Auris, Inc.
Country [1] 289884 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Auris, Inc.
Address
125 Shoreway Road, Suite D
San Carlos, CA 94070
Country
United States of America
Secondary sponsor category [1] 288564 0
None
Name [1] 288564 0
Address [1] 288564 0
Country [1] 288564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291607 0
Comite Etico Cientifico Instituto Costarricense de Investigaciones Clinicas [CEC ICIC]
Ethics committee address [1] 291607 0
Ethics committee country [1] 291607 0
Costa Rica
Date submitted for ethics approval [1] 291607 0
21/08/2014
Approval date [1] 291607 0
11/09/2014
Ethics approval number [1] 291607 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51126 0
Dr Jose Rafael Rojas
Address 51126 0
Hospital Clinica Biblica
Calle Central y Calle 1, Avenida 14
San Jose
Country 51126 0
Costa Rica
Phone 51126 0
+506 8413 7098
Fax 51126 0
Email 51126 0
[email protected]
Contact person for public queries
Name 51127 0
Sam Mostafavi
Address 51127 0
125 Shoreway Road, Suite D
San Carlos, CA 94070
Country 51127 0
United States of America
Phone 51127 0
1 650 209 8698
Fax 51127 0
Email 51127 0
[email protected]
Contact person for scientific queries
Name 51128 0
Sam Mostafavi
Address 51128 0
125 Shoreway Road, Suite D
San Carlos, CA 94070
Country 51128 0
United States of America
Phone 51128 0
1 650 209 8698
Fax 51128 0
Email 51128 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRobotic Bronchoscopy for Diagnosis of Suspected Lung Cancer: A Feasibility Study.2018https://dx.doi.org/10.1097/LBR.0000000000000499
N.B. These documents automatically identified may not have been verified by the study sponsor.