Lung CancerTiLTNCT06056128
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
A study testing Robotic assisted bronchoscopy in people with Lung Cancer and Nodes, Lung, run by Noah Medical at 1 site in Hong Kong.
Trial summary
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nodes, Lung
- What is being tested?
- Robotic assisted bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Aug 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care
- Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung
- Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
- PPNs that are accessible bronchoscopically on planning CT reconstruction
- Informed consent properly obtained per local regulations
Who cannot join
- Known pregnancy or breastfeeding
- Patients with pure ground-glass nodules on pre-procedural chest CT
- Uncontrolled coagulopathy or bleeding disorders
- Ongoing systemic infection
- History of lobectomy or pneumonectomy
- Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
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- Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion
- Patients with pacemakers or defibrillators
- Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin
About this study
Official title: Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Read the detailed description
Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.
- Conditions
- Lung Cancer, Nodes, Lung
- Being tested
- Robotic assisted bronchoscopy
- Keywords
- Lung cancer, robotic assisted bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted bronchoscopyDevice
Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted bronchoscopy | Experimental | Robotic assisted bronchoscopy procedures performed using the Galaxy System. Receives: Device: Robotic assisted bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Measured: During the procedure
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Measured: Up to 7 days post-procedure
Secondary outcomes (2)
Diagnostic yield
Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Measured: Between 7 days and 6 months post-procedure
Center strike as confirmed by CBCT
Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start18 Aug 2023
- Primary completion22 Oct 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Calvin Ng, MD, Principal investigator, Chinese University of Hong Kong, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056128
- Sponsor's protocol ID
- NOAH-002
- Acronym
- TiLT
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study
- ClinicalTrials.gov ID
- NCT06056128
- Acronym / sponsor ID
- TiLT / NOAH-002
- Conditions
- Lung Cancer, Nodes, Lung
- Keywords
- Lung cancer, robotic assisted bronchoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Noah MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Detailed description
Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted bronchoscopy | Experimental | Device: Robotic assisted bronchoscopyRobotic assisted bronchoscopy procedures performed using the Galaxy System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care
- Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung
- Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
- PPNs that are accessible bronchoscopically on planning CT reconstruction
Key exclusion criteria (9 listed)
- Known pregnancy or breastfeeding
- Patients with pure ground-glass nodules on pre-procedural chest CT
- Uncontrolled coagulopathy or bleeding disorders
- Ongoing systemic infection
- History of lobectomy or pneumonectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic assisted bronchoscopyRobotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions | Device | Robotic assisted bronchoscopy |
Primary outcome
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Time frame: During the procedure
Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Time frame: Up to 7 days post-procedure
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
2 secondary outcomes
Diagnostic yield
Time frame: Between 7 days and 6 months post-procedure
Center strike as confirmed by CBCT
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvin Ng, MD principal investigator
Chinese University of Hong Kong, Prince of Wales Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted bronchoscopy in people with Lung Cancer and Nodes, Lung, run by Noah Medical at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT. (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.