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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese University of Hong Kong - Prince of Wales Hospital
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.