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NOT YET RECRUITING
NCT07806981
NA

18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.