NCT07806981Not yet recruiting
18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules
An Exploratory Clinical Study of an 18G Ultrafine Cryoablation Needle for Same-Session Coaxial Transthoracic Biopsy and Cryoablation of Pulmonary Nodules
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07806981
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Sept 2026 to the primary completion date, 1 Apr 2027
- No sites listed in no 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
- Anticoagulant or antiplatelet therapy cannot be safely managed before the procedure according to institutional policy.
- Participation in another clinical study within 30 days before enrollment.
Other illness
- Severe pulmonary fibrosis, pulmonary hypertension, or other severe cardiac, pulmonary, hepatic, renal, neurologic, or systemic organ dysfunction that makes the procedure unsafe.
- Uncontrolled local or systemic infection, including uncontrolled infection near the lesion or access site, or fever above 38.5°C.
- Poorly controlled malignant pleural effusion.
- Active serious psychiatric illness that may interfere with informed consent or study participation.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
Lab values
- Platelet count below 50 × 10\^9/L, clinically significant bleeding tendency, or uncorrectable coagulation disorder.
Other
- Pregnancy or a plan to become pregnant during the study.
Who the study is looking for
- Age 18 years or older.
- One or more pulmonary nodules measuring 3 cm or less on chest CT and considered highly suspicious for malignancy after multidisciplinary review.
- The participant is unsuitable for or declines surgery and radiotherapy after multidisciplinary evaluation and shared decision-making.
- A safe percutaneous access route is available, and the planned ablation zone can cover the target lesion.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Expected survival of at least 12 months.
- The participant or legally authorized representative voluntarily provides written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.