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

NCT07806981 | Not Yet Recruiting

• 1 other identifier: IS26142
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Nodules

Keywords

Pulmonary nodule; Cryoablation; Transthoracic biopsy; Lung cancer

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  Percentage of treated target lesions for which immediate post-ablation imaging shows an ablation zone extending at least 5 mm beyond the target lesion boundary.

  Procedure day

Secondary Outcomes (7)

• Diagnostic yield

  1 months

• Biopsy specimen quality

  1 months

• Complete ablation rate

  Months 3, 6, and 12

• Local control rate

  Months 12, 24, and 36

• Progression-free survival

  Up to 36 months

Study Arms (1)

Same-Session Biopsy and Cryoablation

EXPERIMENTAL

Device: 18G Ultrafine Cryoablation Needle

Interventions

18G Ultrafine Cryoablation Needle DEVICE

An ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics.

Same-Session Biopsy and Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Platelet count below 50 × 10\^9/L, clinically significant bleeding tendency, or uncorrectable coagulation disorder.
• 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.
• Anticoagulant or antiplatelet therapy cannot be safely managed before the procedure according to institutional policy.
• Pregnancy or a plan to become pregnant during the study.
• Active serious psychiatric illness that may interfere with informed consent or study participation.
• Participation in another clinical study within 30 days before enrollment.
• Any other condition that, in the investigator's judgment, makes participation inappropriate.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiayuan Sun

CONTACT

86-021-22200000; xkyyjysun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share