Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001185459
Ethics application status
Approved
Date submitted
20/08/2016
Date registered
29/08/2016
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Date results information initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
First Human Use of an Investigational Bronchoscope System - Assessing Safety and Performance
Scientific title
A Prospective Investigation of the Use of the Intuitive Robotic-Assisted Bronchoscope System (Safety and Feasibility Study) in patients with Pulmonary Nodules of Unknown Etiology
Secondary ID [1] 289981 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Nodules of Unknown Etiology 299987 0
Condition category
Condition code
Respiratory 299880 299880 0 0
Other respiratory disorders / diseases
Cancer 299937 299937 0 0
Lung - Small cell
Cancer 299938 299938 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be screened according to study specific criteria to determine if eligible for the trial. After undergoing pre-procedure assessments which are standard of care for this type of procedure, the subject will be treated according to standard of care, but utilizing the study device under investigation by a trained physician with robust experience in performing bronchoscopy or other pulmonary interventions. The study device is a robotic-assisted bronchoscope system, which is an alternative to a conventional bronchoscope. The approximate duration of the procedure is approximately 1 hour.

Subjects will be monitored prior to discharge and undergo a post-procedure chest x-ray to check for any complications. Subjects are then required to visit their study doctor at 7-days post-procedure for results of the diagnostic intervention and for a general health assessment, and will also undergo a phone or office visit at 90 and 180 day post procedure. Subjects with a non-malignant finding may have data collected from a standard of care follow-up visit at 12 months post-procedure.
Intervention code [1] 295676 0
Diagnosis / Prognosis
Comparator / control treatment
No Comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299357 0
Evaluate safety (through intra and post-procedural complication rates) of the study device under investigation as assessed through the rates of complications seen throughout the trial. Primary safety outcomes are specific to pneumothorax (collapsed lung) and severe bleeding. Complications will be noted in the patients medical record by trained study staff, and entered into a secure, de-identified study specific database.
Timepoint [1] 299357 0
Intra and post-procedure (through 180 days)
Primary outcome [2] 299428 0
Evaluate the feasibility (through number of successful attempts to retrieve tissue samples for diagnosis compared to the number of attempts) of the study device under investigation. Feasibility will be assessed by comparing the number of subjects with a successful tissue sampling relative to the number of subjects with an attempt made.
Timepoint [2] 299428 0
Intra-procedural and post-procedure through 7 days
Secondary outcome [1] 326914 0
Assess overall safety related to the study device, including all adverse events/complications (not just pneumothorax and bleeding). Safety will be assessed by analyzing the rates of complications observed in enrolled subjects. Complications will be noted in the patients medical record by trained study staff, and entered into a secure, de-identified study specific database.
Timepoint [1] 326914 0
through 180 days post-procedure
Secondary outcome [2] 327126 0
Evaluate accuracy characteristics related to the study device. Accuracy characteristics will be assessed though comparing procedure results with post-procedure pathology results.
Timepoint [2] 327126 0
Intra-procedural through 180 days post procedure.

Eligibility
Key inclusion criteria
1) Patients suitable for surgery or intervention, aged 18 years - 75 years
2) Pulmonary nodule(s) (PN) due to suspected lung cancer or metastatic disease or nodule(s) of unknown etiology that require further diagnostic evaluation
3) One or more soft tissue dominant pulmonary nodules between (and including) 10mm and 30 mm in largest dimension on axial plane
4) Nodule completely surrounded by at least 5 mm lung parenchyma, does not touch the hilum or mediastinum, is not associated with adenopathy, atelectasis, or pleural effusion, and the proximal nodule margin (leading edge facing the bronchus & catheter) is more than 1.5 cm distant to the visceral pleura
5) Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information using risk prediction algorithms (as described in the review article of Lam and Tammemagi)
6) PN accessible bronchoscopically on planning CT reconstruction (within 3 cm proximity to PN)
7) Patient able to understand and adhere to study requirements
8) Patient able to provide and sign informed consent
9) Patient not legally incapacitated
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) An inability to tolerate bronchoscopy under endotracheal intubation and general anesthesia.
2) ASA class greater than or equal to 3
3) PN touches the pulmonary hilum or mediastinum, or is associated with adenopathy, lobar atelectasis, or pleural effusion
4) Central PN’s located within the first 3 airway generations (segmental airways, B1-10)
5) The airway leading to the target lesion arises from an aberrant accessory tracheal bronchus
6) Continuous use of anticoagulants (eg, heparin, warfarin) or antiplatelet agents (e.g. Cyclooxygenase Inhibitors (Aspirin), ADP-Receptor inhibitors (Clopidogrel), GP-IIB/IIIA- inhibitors (Abciximac), fish oil, etc) which cannot be discontinued.
7) Uncorrectable coagulopathy or bleeding diathesis
8) Platelet dysfunction or platelet count less than 100×10 to the 9th power
9) History of major bleeding with bronchoscopy
10) Pulmonary hypertension with mean Pulmonary Arterial Pressure (PAP) greater than 25 mm
11) Moderate-to-severe pulmonary fibrosis
12) Severe respiratory insufficiency or hypoxia, moderate-to-severe hypoxemia or any degree of hypercarbia
13) One or more bullae greater than 1 cm located in close vicinity (less than 1cm) of target PN
14) Giant bullae within the same lobe of the target PN
15) Partial tracheal obstruction or obstruction of the superior vena cava
16) Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy for example:
16a) greater than Stage 3 heart failure (NY-Heart Failure Classification)
16b) Unstable hemodynamic status including
16c) Uncontrolled dysrhythmias
16d) History of ventricular arrhythmias
16e) Uncontrolled Hypertension
(Blood Pressure systolic greater than 200mmHg, Blood Pressure diastolic greater than 120mmHg)
16f) Unstable Angina
16g) Myocardial infarction within 6 months
16h) Severe cachexia, debility and malnutrition
16i) Acute Renal or Liver Failure
17) Ongoing systemic acute or chronic infection
18) Pneumonia or acute bronchitis within 3 month of the procedure
19) Lung abscess
20) White Blood Cell (WBC) Count less than 2000 or greater than 20,000
21) Recent head injury or increased intracranial pressure
22) Contraindication to general anesthesia
23) Exposure to radiation treatment or chemotherapy within 3 months prior to the IROB procedure
24) Participation in any other study in last 30 days
25) Prior thoracic surgery on the same side of the lung as the PN or pneumonectomy of the contralateral lung
26) Patients who are pregnant or lactating
27) Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors
28) Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
29) Persons held in an institution by legal or official order, or part of vulnerable population (i.e. mentally disabled)
30) Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2016
Actual
8/09/2016
Date of last participant enrolment
Anticipated
Actual
16/02/2017
Date of last data collection
Anticipated
30/04/2018
Actual
31/07/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294353 0
Commercial sector/Industry
Name [1] 294353 0
Intuitive Surgical
Country [1] 294353 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Intuitive Surgical
Address
1020 Kifer Road
Sunnyvale, CA 94086
Country
United States of America
Secondary sponsor category [1] 293192 0
Commercial sector/Industry
Name [1] 293192 0
Pacific Clinical Research Group Pty Ltd (PCRG)
Address [1] 293192 0
1 Cassins Ave, North Sydney NSW 2060, Australia
Country [1] 293192 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295770 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 295770 0
Level 7, Block 7
Royal Brisbane & Women's Hospital
Herston Qld 4029
Ethics committee country [1] 295770 0
Australia
Date submitted for ethics approval [1] 295770 0
02/06/2016
Approval date [1] 295770 0
12/08/2016
Ethics approval number [1] 295770 0

Summary
Brief summary
First human use clinical trial of an investigational (not-approved) study device used to facilitate the biopsy of pulmonary nodules with unknown etiology. The purpose of this study is to evaluate the safety and feasibility/performance of the investigational device - up to 30 subjects will be enrolled, and will be followed-up for up to 6 months post-procedure. For non-malignant subjects, data may be collected from a standard of care follow-up visit at 12 months post-procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68258 0
Dr David Fielding
Address 68258 0
Butterfield Street
Royal Brisbane & Women's Hospital
Herston Qld 4029
Country 68258 0
Australia
Phone 68258 0
+61 7 36464241
Fax 68258 0
Email 68258 0
david.fielding@health.qld.gov.au
Contact person for public queries
Name 68259 0
Mr Sundeep Master
Address 68259 0
Intuitive Surgical
1020 Kifer Road
Sunnyvale, CA 94086
Country 68259 0
United States of America
Phone 68259 0
+1 408-523-1045
Fax 68259 0
Email 68259 0
sundeep.master@intusurg.com
Contact person for scientific queries
Name 68260 0
Mr Sundeep Master
Address 68260 0
Intuitive Surgical
1020 Kifer Road
Sunnyvale, CA 94086
Country 68260 0
United States of America
Phone 68260 0
+1-408-523-1045
Fax 68260 0
Email 68260 0
sundeep.master@intusurg.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseFirst Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules.2019https://dx.doi.org/10.1159/000498951
N.B. These documents automatically identified may not have been verified by the study sponsor.