Pulmonary NodulesNCT07806981
18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules
A study testing 18G Ultrafine Cryoablation Needle in people with Pulmonary Nodules, run by Shanghai Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- 18G Ultrafine Cryoablation Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Clinical Study of an 18G Ultrafine Cryoablation Needle for Same-Session Coaxial Transthoracic Biopsy and Cryoablation of Pulmonary Nodules
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.
Read the detailed description
All participants will be assigned to a single intervention group. Under CT guidance, a coaxial needle will be positioned near the pulmonary nodule. Biopsy specimens will be obtained before cryoablation. An 18G ultrafine cryoablation needle will then be introduced through the same coaxial tract, and image-guided cryoablation will be performed according to lesion size, shape, and location. A second biopsy may be obtained after ablation. Staged or supplemental ablation is allowed when clinically required. Follow-up assessments include chest CT, safety evaluation, and long-term disease and survival follow-up for up to 36 months.
- Conditions
- Pulmonary Nodules
- Being tested
- 18G Ultrafine Cryoablation Needle
- Keywords
- Pulmonary nodule, Cryoablation, Transthoracic biopsy, Lung cancer
- Medical subject headings
- Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18G Ultrafine Cryoablation NeedleDevice
An ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Same-Session Biopsy and Cryoablation | Experimental | Not described Receives: Device: 18G Ultrafine Cryoablation Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Procedure day
Secondary outcomes (7)
Diagnostic yield
Percentage of biopsied lesions yielding a diagnostic histopathologic result
Measured: 1 months
Biopsy specimen quality
Comparison of pre-ablation and post-ablation specimens using specimen quality with a modified 5-point Likert scale (point 0-4, The higher the score, the better the sample quality.)
Measured: 1 months
Complete ablation rate
Percentage of treated lesions meeting the protocol-defined imaging criteria for complete ablation.
Measured: Months 3, 6, and 12
Local control rate
Percentage of treated lesions without local progression at each scheduled time point.
Measured: Months 12, 24, and 36
Progression-free survival
Time from the study procedure to the first documented disease progression or death from any cause.
Measured: Up to 36 months
Overall survival
Time from the study procedure to death from any cause.
Measured: Up to 36 months
Device- or procedure-related adverse events
Incidence of adverse events assessed by the investigator as related to the device or study procedure
Measured: From the procedure through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806981
- Sponsor's protocol ID
- IS26142
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of an 18G Ultrafine Cryoablation Needle for Same-Session Coaxial Transthoracic Biopsy and Cryoablation of Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT07806981
- Acronym / sponsor ID
- IS26142
- Conditions
- Pulmonary Nodules
- Keywords
- Pulmonary nodule, Cryoablation, Transthoracic biopsy, Lung cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All participants will be assigned to a single intervention group. Under CT guidance, a coaxial needle will be positioned near the pulmonary nodule. Biopsy specimens will be obtained before cryoablation. An 18G ultrafine cryoablation needle will then be introduced through the same coaxial tract, and image-guided cryoablation will be performed according to lesion size, shape, and location. A second biopsy may be obtained after ablation. Staged or supplemental ablation is allowed when clinically required. Follow-up assessments include chest CT, safety evaluation, and long-term disease and survival follow-up for up to 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Same-Session Biopsy and Cryoablation | Experimental | Device: 18G Ultrafine Cryoablation Needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18G Ultrafine Cryoablation NeedleAn ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics. | Device | Same-Session Biopsy and Cryoablation |
Primary outcome
Technical success rate
Time frame: Procedure day
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.
7 secondary outcomes
Diagnostic yield
Time frame: 1 months
Biopsy specimen quality
Time frame: 1 months
Complete ablation rate
Time frame: Months 3, 6, and 12
Local control rate
Time frame: Months 12, 24, and 36
Progression-free survival
Time frame: Up to 36 months
Overall survival
Time frame: Up to 36 months
Device- or procedure-related adverse events
Time frame: From the procedure through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 18G Ultrafine Cryoablation Needle in people with Pulmonary Nodules, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun (86-021-22200000, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: Procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.