Lung CancerMatch 2NCT06685133
Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
An observational study of Lung Cancer and Lung; Nodule, run by Noah Medical at 2 sites in United States.
Trial summary
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung; Nodule
- What is being tested?
- Robotic assisted bronchoscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2024to 30 Oct 2027
- Phase
- Observational
- 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
Study population: Clinic patients
Who may be able to join
- Age ≥ 18
- Patients with indeterminate lung nodule
- Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
- Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
- 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
- Patients with pacemakers or defibrillators
- Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
- Patients with pleural effusion or diaphragmatic paralysis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CHI Memorial Hospital
Chattanooga, Tennessee, 37404
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
About this study
Official title: A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
Read the detailed description
The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.
- Conditions
- Lung Cancer, Lung; Nodule
- Being tested
- 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
Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Subjects who undergo bronchoscopy of the airways 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 Navigation to the lesion
Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.
Measured: During the procedure
Successful tool-in-lesion
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Measured: During the procedure
Serious Adverse Events
Serious device or procedure related adverse events
Measured: During the procedure and 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: End of procedure and up to 2-years post-procedure
Center Strike
Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.
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 posted12 Nov 2024
- Study start8 Nov 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noah Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685133
- Sponsor's protocol ID
- NOAH-003
- Acronym
- Match 2
- Status last verified
- Aug 2025
- First submitted
- 9 Nov 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mahajan AK, Duong DK, Cortes J, Bhadra K. The match 2 study: Robotic assisted bronchoscopy with integrated imaging with assessment of digital tomosynthesis (DT) and augmented fluoroscopy (AF): Three-Dimensional accuracy as confirmed by cone beam computed tomography (CBCT). Respir Med. 2026 Mar;253:108693. doi: 10.1016/j.rmed.2026.108693. Epub 2026 Jan 29.
PubMed 41620189
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
- ClinicalTrials.gov ID
- NCT06685133
- Acronym / sponsor ID
- Match 2 / NOAH-003
- Conditions
- Lung Cancer, Lung; Nodule
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Noah MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
Detailed description
The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | – | Device: Robotic assisted bronchoscopySubjects who undergo bronchoscopy of the airways using the Galaxy System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic patients
Key inclusion criteria (5 listed)
- Age ≥ 18
- Patients with indeterminate lung nodule
- Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
- Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
- Informed consent properly obtained per local regulations
Key exclusion criteria (8 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 bronchoscopySubjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules. | Device | Intervention/Treatment |
Primary outcome
Successful Navigation to the lesion
Time frame: During the procedure
Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.
Successful tool-in-lesion
Time frame: During the procedure
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Serious Adverse Events
Time frame: During the procedure and up to 7 days post procedure
Serious device or procedure related adverse events
2 secondary outcomes
Diagnostic yield
Time frame: End of procedure and up to 2-years post-procedure
Center Strike
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 15 Aug 2025.
- Derived from this study: PubMed 41620189Mahajan AK, Duong DK, Cortes J, Bhadra K. The match 2 study: Robotic assisted bronchoscopy with integrated imaging with assessment of digital tomosynthesis (DT) and augmented fluoroscopy (AF): Three-Dimensional accuracy as confirmed by cone beam computed tomography (CBCT). Respir Med. 2026 Mar;253:108693. doi: 10.1016/j.rmed.2026.108693. Epub 2026 Jan 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung; Nodule, run by Noah Medical at 2 sites in United States.
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 5 inclusion and 8 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 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Navigation to the lesion (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06685133, which also lists 1 linked publication.
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 15 Aug 2025.