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18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules
Sponsor: Shanghai Chest Hospital
Summary
This prospective, single-center clinical study will evaluate whether an 18-gauge ultrafine cryoablation needle can be used feasibly and safely during CT-guided coaxial transthoracic biopsy of pulmonary nodules. Approximately 30 adults with pulmonary nodules highly suspected of malignancy who are unsuitable for or decline surgery or radiotherapy will undergo biopsy and cryoablation during the same procedure. The study will assess technical success, biopsy diagnostic performance, imaging-based local control, and device- or procedure-related adverse events. Participants will be followed for up to 36 months. The study hypothesis is that the same-tract procedure is technically feasible and provides acceptable safety and local disease control.
Official title: An Exploratory Clinical Study of an 18G Ultrafine Cryoablation Needle for Same-Session Coaxial Transthoracic Biopsy and Cryoablation of Pulmonary Nodules
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09-01
Completion Date
2030-04-01
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
18G Ultrafine Cryoablation Needle
An ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics.