NCT06056128Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 18 Aug 2023
- Primary completion date
- 22 Oct 2024
- Lead sponsor
- Noah Medical
- Diseases
- Lung cancer
- NCT number
- NCT06056128
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 18 Aug 2023 to the primary completion date, 22 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
Other illness
- Uncontrolled coagulopathy or bleeding disorders
- Ongoing systemic infection
- History of lobectomy or pneumonectomy
Other
- Known pregnancy or breastfeeding
- Patients with pure ground-glass nodules on pre-procedural chest CT
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese University of Hong Kong - Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.