Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC
NCT07741344 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 292
Last updated 2026-08-03
Summary
This study aims to address the core deficiencies in the field by situating bronchoscopic ablation within the same evidentiary frame as segmentectomy and lobectomy. It will deliver adjusted retrospective comparisons with external validation using population data, a prospective noninferiority evaluation on disease control and safety, quantitative evidence on pulmonary function and quality of life, and translational endpoints linking circulating tumour DNA (ctDNA) dynamics and immune activation to durability of control. The work is directly aligned with Hong Kong service needs, where a safe lung preserving option that shortens recovery and optimises resource use could relieve surgical waiting pressure while maintaining oncologic outcomes.
Conditions
- Stage IA NSCLC
Interventions
- PROCEDURE
-
Bronchoscopic Microwave Ablation
The study doctor perform robotic-assisted or electromagnetic navigation bronchoscopy to locate the target lung lesion, deliver the ablation catheter through the bronchus to the target site for lesion puncture, and conduct microwave ablation. After the surgery, CBCT scanning is conducted to evaluate the ablation effect, and repeated ablation is performed as needed.
- PROCEDURE
-
Surgical Resection
The study doctor will begin by opening the hilar pleural reflection, followed by dissection of and division of lobar / segmental vein and artery by endostaplers. Segmental or lobar bronchus is dissected out and stapled. Lymphadenectomy will be performed and the specimens will be retrieved using protective bags via utility wound. This lung tissue specimen may also be analysed for research purpose.
Sponsors & Collaborators
-
Chinese University of Hong Kong
lead OTHER
Principal Investigators
-
Calvin Sze Hang Ng · CUHK
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2026-11-30
- Completion
- 2029-12-31
- FDA Device
- Yes
Countries
- Hong Kong
Study Locations
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