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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001347358p
Ethics application status
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Submitted, not yet approved
Date submitted
Help: Date submitted
15/08/2026
Date registered
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10/11/2026
Date last updated
Help: Date last updated
10/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/11/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Cost-effectiveness Of Multimodal Pulmonary nodule Assessment strategies using Shape-sensing robotic-assisted bronchoscopy in patients with suspected lung cancer (the COMPASS Study)
Scientific title
Cost-effectiveness Of Multimodal Pulmonary nodule Assessment strategies using Shape-sensing robotic-assisted bronchoscopy in patients with suspected lung cancer (the COMPASS Study)
Additional trial identifiers [1] 317948 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMPASS Study
Related trial records

Health condition
Health condition(s) studied:
Lung nodules requiring biopsy 343243 0
Suspected lung cancer 343311 0
Condition category
Condition code
Respiratory 339351 339351 0 0
Other respiratory disorders / diseases
Cancer 339352 339352 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: Robotic-assisted bronchoscopy with cone-beam CT guidance (RAB-CBCT), approximately 100 cases in total, comprising a retrospective group and a prospective group.

Adults referred for bronchoscopic biopsy of a peripheral lung nodule at Royal Prince Alfred Hospital (RPAH) have shape-sensing robotic-assisted bronchoscopy with intraoperative cone-beam CT (CBCT). The procedure is standard clinical care at RPAH and is not changed by the study. For the prospective group, research activities are: recording of procedural data; the EQ-5D-5L quality-of-life questionnaire before the procedure, at 7–14 days and at 4–6 weeks; and review of medical records up to 12 months after the procedure. The proceduralist also completes a short workload rating (NASA Task Load Index, Mental Demand subscale).

Retrospective group: patients who underwent robotic bronchoscopy at RPAH as routine clinical care prior to ethics approval (approximately 15 to date). No research activity took place at the time of their procedure. After ethics approval, these patients will be asked for consent to the use of their medical records. Their procedural, cost and outcome data up to 12 months will be obtained from the medical records. They will not complete questionnaires. All robotic cases, retrospective and prospective, are included in the analysis. Each case is numbered from the first robotic case at RPAH so that results can be assessed for a learning curve.

How patients are assigned to a procedure: the treating clinician decides on standard clinical grounds whether a patient is referred for robotic bronchoscopy or for CT-guided percutaneous needle biopsy. These grounds include nodule size, location and features, fitness for general anaesthesia, and whether a bronchoscopic approach is suitable. This decision is made at the RPAH Lung Nodule Clinic before the research consent discussion. Patients are then invited to the study arm that matches the procedure they have already been referred for. Allocation is not randomised and is not based on patient preference. Taking part in the research does not influence which procedure a patient receives.

Before the procedure: a clinical assessment at the Lung Nodule Clinic confirms fitness for general anaesthesia and suitability for bronchoscopy, as part of routine workup before the procedure date. This assessment usually takes approximately 1 hour. The proceduralist plans the airway route to the nodule from the pre-procedure CT scan using the system's planning software.

Anaesthesia: the procedure is done under general anaesthesia with an endotracheal tube, neuromuscular blockade and controlled mechanical ventilation. Controlled ventilation lets the anaesthetist pause breathing briefly while CBCT images are taken. Anaesthetic agents, doses and ventilator settings follow standard RPAH practice and are adjusted to each patient by the anaesthetist.

The procedure: the procedure takes place in the RPAH hybrid operating theatre, which has fixed CBCT. The robotic catheter is passed through the endotracheal tube and steered to the nodule. Radial endobronchial ultrasound (radial EBUS) is used to check that the catheter has reached the nodule. A CBCT scan ("spin") of about 5–8 seconds is then taken during a brief breath-hold to confirm the biopsy tool is in the nodule. CBCT is done in every case. If the first scan shows the tool is not in the nodule, the catheter is repositioned and a further scan is taken; this is expected in about 20% of cases. Biopsies are taken under fluoroscopy, using biopsy tools chosen by the proceduralist. Rapid on-site evaluation (ROSE) by a cytologist is available in every case and shows within minutes whether the sample is adequate, so more samples can be taken if needed. Where clinically indicated (about 25% of cases), lymph nodes in the centre of the chest are also sampled in the same procedure by linear endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The procedure usually takes about 1 hour including anaesthesia. It takes longer if more than one nodule is sampled or lymph node staging is needed.

Device: the Ion Endoluminal System (Intuitive Surgical Inc.) is a shape-sensing robotic bronchoscopy platform. It is included on the Australian Register of Therapeutic Goods (ARTG 473548, 472286, 484785) and is used within its approved intended purpose: to help navigate and position instruments in the airways for diagnostic procedures. Route planning uses the system's PlanPoint software. No device is implanted or left in the body. The catheter is removed at the end of the procedure.

After the procedure: patients recover in the post-anaesthesia recovery unit. This is a day procedure and most patients go home the same day. Biopsy samples are examined by a pathologist in the hospital laboratory. The formal report is usually available within 2–5 days and is sent to the participant's referring doctor. Results and further care are managed through routine clinical care.

Number of procedures: each participant has one procedure, on one day. A repeat procedure is not part of the intervention. If a repeat procedure is needed because of a non-diagnostic result, it is recorded as a study outcome (re-procedure rate).

Checking the procedure is delivered as planned: all procedures are done by credentialed RPAH interventional pulmonologists. Whether a trained proctor was present is recorded for each case. For every case the study records the number of CBCT scans, whether repositioning was needed, whether a further CBCT scan was taken after a non-confirmatory ROSE result, and the radial EBUS signal grade. Radial EBUS signal grade is compared against the CBCT-confirmed tool position. Together these records show, case by case, whether the procedure was delivered as planned. For the retrospective group, these items are obtained from the procedure records.
Intervention code [1] 335080 0
Diagnosis / Prognosis
Description of the comparator or control
Arm 2: Prospective CT-guided percutaneous needle biopsy (PCNB) sub-cohort, n=30.

Adults referred for CT-guided percutaneous needle biopsy of a lung nodule at RPAH, on the clinical grounds described for Arm 1. The biopsy is standard clinical care, done by credentialed interventional radiologists, and is not changed by the study. No research procedures take place on the procedure day. Research activities are the EQ-5D-5L questionnaire before the procedure, at 7–14 days and at 4–6 weeks, and review of medical records.

Before the procedure: referral and workup are through the interventional radiology pathway, from the same Lung Nodule Clinic referral point as Arm 1. This includes review of the pre-procedure CT scan and blood clotting tests. Consent for the clinical procedure is obtained separately from research consent.

Anaesthesia: most procedures are done with the patient awake and breathing normally, using local anaesthetic at the needle entry site only, without sedation. Sedation or general anaesthesia is used only when clinically needed, which is uncommon.

The procedure: the procedure takes place in the RPAH radiology department. The patient lies on the CT table. Local anaesthetic is injected into the skin and chest wall at the needle entry site. During brief breath-holds, the radiologist guides a needle through the chest wall to the nodule, using repeated CT scans to check the needle path and position before sampling. This CT check confirms the needle is in the nodule, as CBCT does in Arm 1. A coaxial system is usually used: an outer introducer needle stays in place and a core biopsy needle is passed through it, so several samples can be taken through one skin entry point. ROSE by a cytologist is generally used to check sample adequacy and guide the number of samples taken. A final CT scan checks for immediate complications, such as a collapsed lung (pneumothorax), before the needle is removed. The procedure usually takes under an hour.

Device: the procedure uses a CT scanner for guidance and a standard percutaneous biopsy needle system. No device is implanted or left in the body. The needle is removed at the end of the procedure.

After the procedure: patients are monitored in recovery. A chest X-ray is taken before discharge to check for delayed pneumothorax. Most patients go home the same day. Patients are admitted overnight if a complication needs monitoring or treatment, such as a chest drain for pneumothorax. Samples are examined by a pathologist in the hospital laboratory. The formal report is usually available within 2–5 days and is sent to the participant's referring doctor.

Number of procedures: each participant has one procedure, on one day. If a repeat procedure is needed because of a non-diagnostic result, it is recorded as a study outcome, not as part of the planned procedure.

Checking the procedure is delivered as planned: procedures are done by credentialed interventional radiologists using standard RPAH technique. CT confirmation of needle position before sampling, and ROSE, provide a check on each procedure.

Arm 3: Retrospective PCNB cohort, n=95.

Patients who had CT-guided percutaneous needle biopsy at RPAH in the 2023–24 financial year as part of routine care, before this study began. No procedure, contact or questionnaire takes place under this study. Existing clinical, procedural, pathology, cost and outcome data are drawn from the SLHD Bronchoscopy and Pleural Registry (LINGULA sub-study, HREC 2024/ETH01851), under that project's existing approvals. Each patient had one PCNB with formal pathology assessment. Quality control for this arm is checking that the data extraction is complete and accurate. Arm 3 is the main comparator for the cost-effectiveness analysis.
Control group
Active

Outcomes
Primary outcome [1] 346557 0
Cost-effectiveness (incremental cost-effectiveness ratio, cost per quality-adjusted life-year, QALY). This is a single outcome, not a composite. Arm 1 versus the combined PCNB comparator (Arms 2 and 3)
Timepoint [1] 346557 0
12-months post diagnosis
Secondary outcome [1] 466367 0
Health status (Arm 1 prospective group, Arm 2)
Timepoint [1] 466367 0
baseline (pre-procedure), D7–14, and 4–6 weeks post-procedure.
Secondary outcome [2] 466368 0
Diagnostic yield (Arm 1,2,3)
Timepoint [2] 466368 0
Ascertained when biopsy results reported (post-procedure); benign results verified at 12-months post-procedure (medical record).
Secondary outcome [3] 466369 0
Serious Complication Rate: Arm 1 versus the combined PCNB comparator (Arms 2 and 3)
Timepoint [3] 466369 0
Ascertained at D7–14, 4-6 weeks, 12 months post-procedure (medical record and patient reporting).
Secondary outcome [4] 466370 0
Re-procedure rate (Arm 1,2,3)
Timepoint [4] 466370 0
12 months after the index procedure.
Secondary outcome [5] 466371 0
Time to pathological diagnosis (Arm 1,2,3)
Timepoint [5] 466371 0
Ascertained from medical record when biopsy results reported and published (post-procedure).
Secondary outcome [6] 466372 0
Cost per Confirmed Diagnosis (Arm 1,2,3)
Timepoint [6] 466372 0
Derived from the economic model at study completion (last recruited subject at 12 months post-procedure).
Secondary outcome [7] 466373 0
Avoided Second-Procedure Costs (Concurrent staging endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) Cases); Arm 1,2,3
Timepoint [7] 466373 0
Ascertained from the electronic medical record (procedure case report/bronchoscopy report) at the index RAB-CBCT procedure, since whether concurrent EBUS-TBNA was performed is recorded at the time of that procedure.
Secondary outcome [8] 466374 0
Budget impact analysis (Arm 1,2,3)
Timepoint [8] 466374 0
Derived at study completion
Secondary outcome [9] 466375 0
CBCT-Guided biopsy tool repositioning rate (Diagnostic Yield proxy for standalone RAB, ie without CBCT guidance); Arm 1
Timepoint [9] 466375 0
Recorded intraoperatively for all RAB cases
Secondary outcome [10] 466376 0
CBCT Yield Increment Threshold (Arm 1)
Timepoint [10] 466376 0
At study completion
Secondary outcome [11] 466377 0
Proceduralist workload assessed as a composite outcome (NASA Task Load Index, all 6 domains: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, Frustration) (Arm 1, proceduralists only)
Timepoint [11] 466377 0
Day of procedure, completed by interventional bronchoscopists
Secondary outcome [12] 466833 0
Attributable Costs of Serious Complications: Arm 1 versus the combined PCNB comparator (Arms 2 and 3).
Timepoint [12] 466833 0
At study completion during data analysis

Eligibility
Key inclusion criteria
• Disease status: Adults with a high-risk peripheral pulmonary nodule (screen-detected or incidentally identified), referred for diagnostic biopsy at participating tertiary hospitals, including cases requiring concurrent EBUS-guided mediastinal nodal sampling.
• Sex: All sexes.
• Age range: 18 years and older.
• Informed consent: Willingness to provide informed consent and participate in study data collection.
• Retrospective robotic group: adults who underwent robotic bronchoscopy for a peripheral lung nodule at RPAH as routine clinical care prior to ethics approval.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Lacks capacity to provide informed consent as determined by the treating clinician.
• Age under 18 years.
• Incomplete procedural or outcome records precluding extraction of primary endpoints.
• RAB performed for an indication other than diagnostic tissue acquisition (e.g. therapeutic or interventional procedures).

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Formal a priori power calculation is not applicable to decision-analytic cost-effectiveness modelling. The required inputs are parameter estimates with associated uncertainty distributions rather than subject-level data sufficient to detect a pre-specified effect size. Sample size for the prospective RAB cohort is therefore determined by the number of procedures anticipated within the study period and by the precision required for empirical cost and utility inputs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/12/2026
Actual
Date of last participant enrolment
Anticipated
16/08/2027
Actual
Date of last data collection
Anticipated
28/08/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29993 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 46391 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 322496 0
Government body
Name [1] 322496 0
Agency for Clinical Innovation - NSW Health
Country [1] 322496 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325672 0
None
Name [1] 325672 0
Address [1] 325672 0
Country [1] 325672 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320975 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 320975 0
Ethics committee country [1] 320975 0
Australia
Date submitted for ethics approval [1] 320975 0
24/07/2026
Approval date [1] 320975 0
Ethics approval number [1] 320975 0

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

Contacts
Principal investigator
Name 152258 0
A/Prof Lauren Troy
Address 152258 0
Respiratory Medicine, Royal Prince Alfred Hospital, 50 Missenden Road, CAMPERDOWN, NSW 2050
Country 152258 0
Australia
Phone 152258 0
+61 2 9515 7427
Fax 152258 0
Email 152258 0
[email protected]
Contact person for public queries
Name 152259 0
Lauren Troy
Address 152259 0
Respiratory Medicine, Royal Prince Alfred Hospital, 50 Missenden Road, CAMPERDOWN, NSW 2050
Country 152259 0
Australia
Phone 152259 0
+61 2 9515 7427
Fax 152259 0
Email 152259 0
[email protected]
Contact person for scientific queries
Name 152260 0
Lauren Troy
Address 152260 0
Respiratory Medicine, Royal Prince Alfred Hospital, 50 Missenden Road, CAMPERDOWN, NSW 2050
Country 152260 0
Australia
Phone 152260 0
+61 2 9515 7427
Fax 152260 0
Email 152260 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Researchers with study proposals requesting data access can email the sponsor (SLHD HREC - RPAH Zone, [email protected]) or the trial custodian (Study CPI, [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


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.