Clinical trial · Observational
Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
NCT06685133CI-TRIAL-00093729Match 2active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung; Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic assisted bronchoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intervention/Treatment
- description
- Subjects who undergo bronchoscopy of the airways using the Galaxy System.
- interventionNames
- Device: Robotic assisted bronchoscopy
Primary outcomes (3)
- measure
- Successful Navigation to the lesion
- timeFrame
- During the procedure
- description
- Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.
- measure
- Successful tool-in-lesion
- timeFrame
- During the procedure
- description
- Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 2. Patients with indeterminate lung nodule 3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT 4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure 5. Informed consent properly obtained per local regulations Exclusion Criteria: 1. Known pregnancy or breastfeeding 2. Patients with pure ground-glass nodules on pre-procedural chest CT 3. Uncontrolled coagulopathy or bleeding disorders 4. Ongoing systemic infection 5. History of lobectomy or pneumonectomy 6. Patients with pacemakers or defibrillators 7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist 8. Patients with pleural effusion or diaphragmatic paralysis
References
Publications (1)
- DERIVEDMahajan 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. PMID 41620189