Clinical trial · Interventional
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
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
NCT06056128CI-TRIAL-00088910TiLTactive not recruitingN/AClinicalTrials.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)
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
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 |
| Nodes, Lung | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic assisted bronchoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic assisted bronchoscopy
- description
- Robotic assisted bronchoscopy procedures performed using the Galaxy System.
- interventionNames
- Device: Robotic assisted bronchoscopy
Primary outcomes (2)
- measure
- Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
- timeFrame
- During the procedure
- description
- 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.
- measure
- Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
- timeFrame
- Up to 7 days post-procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 2. 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 3. 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 4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure 5. PPNs that are accessible bronchoscopically on planning CT reconstruction 6. 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. Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. 7. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion 8. Patients with pacemakers or defibrillators 9. Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
References
Publications (0)
Data not yet available
No reference posted for this study.