Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001440718
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
8/02/2024
Date data sharing statement initially provided
10/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Noah Medical FRONTIER Study: First Human Use of a New Robotic Electromagnetic Navigation Bronchoscopy with Integrated Tool-In-Lesion-Tomosynthesis (TiLT) Technology (Galaxy System) for Small Peripheral Pulmonary Nodules
Scientific title
First Human Use of a New Robotic ElectrOmagnetic Navigation Bronchoscopy with Integrated Tool-In-Lesion-Tomosynthesis (TiLT) TEchnology (Galaxy SystemTM) for Small PeRipheral Pulmonary Nodules
Secondary ID [1] 308337 0
None
Universal Trial Number (UTN)
Trial acronym
FRONTIER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Pulmonary Nodules 328127 0
Condition category
Condition code
Respiratory 325180 325180 0 0
Other respiratory disorders / diseases
Cancer 325210 325210 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the Noah Medical Galaxy Robotic Bronchoscopy System for the biopsy of small peripheral pulmonary nodules, will be performed in a bronchoscopy suite by a specialist respiratory physician (interventional pulmonologist).
Prior to the interventional pulmonologist performing the procedure in the clinical trial they will have been trained by a suitably qualified representative from the sponsor (Noah Medical) in a didactic and practical training lab (performed at Macquarie University Clinical Training Unit). The subject will be anaesthetised by a qualified anaesthetist using mechanisms that are suitable for that particular subject.
Subjects may have more than one nodule sampled but will only have one procedure under the Galaxy System protocol. if further nodules are to be sampled at a later stage these will be sampled using standard of care techniques.
It is anticipated that the procedure will take approximately one hour.
The preparation and post operative follow up will be according to standard of care for a subject undergoing bronchoscopic biopsy of a small peripheral pulmonary nodule. This includes physical exam, medical history, CT of Chest (lung) and respiratory function tests to assess lung function. These assessments are standard for subjects undergoing bronchoscopic biopsy of lung nodules.
The Noah Medical Galaxy Biopsy system uses a CT Scan of the Chest obtained from the subject to identify the area of lung in which the nodule exists. The data from this CT is used by the Galaxy system to navigate to the lung region in order to biopsy the nodule.
In the unlikely occurrence that the Galaxy System cannot access the lung nodule for biopsy, an attempt will be made using standard of care approaches including the use of radial EBUS (endobronchial ultrasound) and fluoroscopy.
Intervention code [1] 324787 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333009 0
Primary Efficacy Outcome 1: Assessment of feasibility of using the Galaxy System to bronchoscopically biopsy small peripheral pulmonary nodules between 1-3 cm. This will be determined by Case Report Forms determining efficacy in sampling nodules including feedback from interventional pulmonologists gained during and after the procedure in informal interviews. Diagnostic yield of biopsies obtained will also be assessed by pathological samples.
Timepoint [1] 333009 0
At the completion of the Galaxy Bronchoscopy procedure by interventional pulmonologists assessment of ability to sample pulmonary nodules and pathology assessment of sampled tissue.
Primary outcome [2] 333010 0
Primary Efficacy Outcome 2: Successful navigation to the peripheral pulmonary nodules confirmed by radial endobronchial ultrasound (EBUS).
Timepoint [2] 333010 0
At the completion of the Galaxy Bronchoscopy procedure as determined by interventional pulmonologist utilising radial endobronchial ultrasound and pathology testing of tissue.
Primary outcome [3] 333012 0
Primary Safety Outcome: measurement of serious device or procedure adverse events during the bronchoscopy procedure and post-procedure (up to 7 days) assessed by clinical exam and chest x-ray (but not limited to). Such procedural adverse events may include pneumothorax and bleeding episodes from biopsy site.
Timepoint [3] 333012 0
At 7 days following the Galaxy Bronchoscopy procedure as assessed by physical exam, patient history since Galaxy procedure and chest x-ray (but not limited)
Secondary outcome [1] 415527 0
Tool-in-lesion confirmation by tomosynthesis
Timepoint [1] 415527 0
At the completion of the Galaxy Bronchoscopy Procedure
Secondary outcome [2] 415530 0
Confirmed malignancy rate at final pathology post procedure following the pathological review of tissue obtained during the Galaxy Bronchoscopy Procedure
Timepoint [2] 415530 0
Within 7 days post-Galaxy bronchoscopy procedure if diagnosis was positive for cancer or within 6 months post-Galaxy bronchoscopy procedure if diagnosis was determined to be non-cancerous or unable to be made
Secondary outcome [3] 415533 0
Assessment of All adverse events up to 7 days post-procedure including pneumothorax, hemothorax and infection as determined by physical exam, subject's medical history and chest x-ray (but not limited to)
Timepoint [3] 415533 0
At 7 days post Galaxy Bronchoscopy Procedure

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years of age
Patients with a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information, determined by the Interventional Pulmonary Nodule MDT based on the site’s standard of care
Solid peripheral pulmonary nodules (PPNs) sized 1 to 3 cm measured as the largest dimension
Pre-procedural CT is conducted within 30 days of the bronchoscopy procedure
Peripheral Pulmonary Nodules that are accessible bronchoscopically on planning CT reconstruction based on MDT discussion
Informed consent properly obtained per local regulations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known pregnancy or breastfeeding
Patients with a subsolid nodule (pure or partly solid ground-glass nodules) on pre-procedural chest CT
Uncontrolled coagulopathy or bleeding disorders
Ongoing systemic infection
Past history of lobectomy
Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
Moderate-to-severe hypoxia, hypoxemia, or hypercarbia
Patients with implanted pacemakers or defibrillators
Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Patients who are unable to provide written informed consent to participate in the study

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/efficacy
Statistical methods / analysis
The sample size for this protocol is too small to permit a formal statistical analysis. Trends, particularly in reported adverse events, will be noted and characterized. A comprehensive listing, categorization, and assessment of causality will be provided for all serious and non-serious adverse events secondary to the Galaxy procedure. Descriptive statistics will be used to summarize the secondary outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
2/05/2023
Date of last data collection
Anticipated
1/01/2024
Actual
2/06/2023
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23498 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 38904 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 312581 0
Commercial sector/Industry
Name [1] 312581 0
Noah Medical Inc.
Country [1] 312581 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Noah Medical Inc
Address
1501 Industrial Rd,
San Carlos, CA 94070, USA
Country
United States of America
Secondary sponsor category [1] 314190 0
Commercial sector/Industry
Name [1] 314190 0
Australian Healthcare Solutions Pty Ltd
Address [1] 314190 0
Level 1 / 424 Burke Road
Camberwell, Victoria, 3124
Country [1] 314190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311907 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 311907 0
Ethics committee country [1] 311907 0
Australia
Date submitted for ethics approval [1] 311907 0
21/09/2022
Approval date [1] 311907 0
27/10/2022
Ethics approval number [1] 311907 0
520221235642397

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

Contacts
Principal investigator
Name 122798 0
Prof Alvin Ing
Address 122798 0
Macquarie Respiratory and Sleep
2 Technology Place
Macquarie University, NSW 2109
Country 122798 0
Australia
Phone 122798 0
+61298123709
Fax 122798 0
Email 122798 0
[email protected]
Contact person for public queries
Name 122799 0
Matthew Godden
Address 122799 0
Australian Healthcare Solutions Pty Ltd.
Level 1 / 424 Burke Road
Camberwell, Vic, 3124
Country 122799 0
Australia
Phone 122799 0
+61400007127
Fax 122799 0
Email 122799 0
[email protected]
Contact person for scientific queries
Name 122800 0
Song Liu
Address 122800 0
Noah Medical Inc.
1501 Industrial Rd,
San Carlos, CA 94070, USA
Country 122800 0
United States of America
Phone 122800 0
+14087170987
Fax 122800 0
Email 122800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is only being published as a batch - not on an individual basis.


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
No additional documents have been identified.