Percutaneous Lung AblationNCT07105813
A Clinical Trial of Percutaneous Lung Ablation Using Navigational Positioning Robot-assisted Procedures
A study testing Navigational Positioning System for Puncture Surgery in people with Percutaneous Lung Ablation, run by Xiaolong Yan, Dr..
Trial summary
The purpose of the trial is to exploratively evaluate the safety and efficacy of the Puncture Surgery Navigation and Positioning System for CT-guided percutaneous lung ablation procedures for multiple ground glass nodules. Thirty subjects are planned to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Lung Ablation
- What is being tested?
- Navigational Positioning System for Puncture Surgery
- 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
- 15 Sep 2025to 30 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and <80 years, regardless of sex;
- Diagnosis of persistent multiple pulmonary ground glass nodules (GGN), including pure ground glass nodules (pGGN) and mixed ground glass nodules (mGGN), with no limitation on the size and number of nodules, where persistence is defined as the non-resolution of the GGN after 3 months of follow-up after detection;
- Patients who are evaluated as needing treatment for a primary or secondary lesion of a ground glass nodule in the lung, and the diameter of the lesion to be ablated is ≥6.0 mm, and who meet any of the following can be enrolled:
- Cannot tolerate surgical resection due to poor cardiopulmonary function or advanced age;
- Refuse to undergo surgical resection;
- Residual lesions or new lesions after surgical resection;
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- Severe pleural adhesions or pleural cavity atresia from various causes;
- Single lung (absence of one side of the lung from various causes);
- Severe anxiety that is not relieved by psychological or pharmacological treatment.
- The patient fully understands the benefits and risks of this trial, is willing to participate in the trial and signs an informed consent form.
Who cannot join
- Those with skin redness, swelling, broken skin, symptoms of skin diseases at the puncture site, dermatologic diseases that cannot be affixed with markers, or acute suppurative infections in the pleural cavity;
- Platelets <50 × 109/L, or severe bleeding tendency, coagulation dysfunction that cannot be corrected in a short period of time (prothrombin time >18 s, plasminogen activity <40%), or anticoagulant therapy and/or antiplatelet drugs that have not been discontinued for more than 5 d to 7 d prior to ablation, and the interval between the last use of bevacizumab has not exceeded 1 month;
- Those with severe systemic infection and high fever (>38.5°C);
- Lung nodules close to important organs such as mediastinum or cardiac great vessels;
- Those who have other diseases such as pulmonary pustules or pulmonary cysts leading to pneumothorax in the proposed puncture path, or those who have obvious infectious lesions in the puncture path;
- Those with poorly controlled pleural effusion;
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- Severe pulmonary fibrosis and pulmonary hypertension;
- Those with severe cardiac, hepatic, pulmonary, renal, or cerebral insufficiency;
- Those with severe anemia, dehydration, and severe disorders of nutritional metabolism that cannot be corrected or improved in the short term;
- Those with an Eastern Cooperative Oncology Group (ECOG) score >3;
- Patients with episodic psychosis;
- Those with a combination of other tumors with extensive metastases and an expected survival of <6 months;
- Those who cannot cooperate, those who cannot control cough, and those who cannot tolerate puncture;
- Women who are in pregnancy or breastfeeding, and others who cannot receive intraoperative radiation;
- Those who have participated or are participating in another clinical trial within 28 days prior to screening;
- Subjects who are assessed by the investigator to have poor compliance or other reasons why they should not participate in the trial.
About this study
Official title: A Clinical Trial of the Safety and Efficacy of a Perforated Surgical Navigation and Localization System for Use in Percutaneous Pulmonary Ablation of Multiple Ground-glass Nodules
The purpose of the trial is to exploratively evaluate the safety and efficacy of the Puncture Surgery Navigation and Positioning System for CT-guided percutaneous lung ablation procedures for multiple ground glass nodules.
Thirty subjects are planned to be enrolled in this study. In the study, it is planned to perform CT-guided percutaneous lung ablation procedures in the enrolled patients using the Puncture Surgery Navigation and Positioning System, and to evaluate the technical success rate, puncture accuracy, one-time technical success rate, one-needle penetration in place, number of needle adjustments, time to puncture, and complication rate
- Conditions
- Percutaneous Lung Ablation
- Being tested
- Navigational Positioning System for Puncture Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigational Positioning System for Puncture SurgeryDevice
Suitable for puncture surgery navigation and localization systems to assist in the procedure
| Study group | Role | What they receive |
|---|---|---|
| Navigational Positioning System for Puncture Surgery | Experimental | Not described Receives: Device: Navigational Positioning System for Puncture Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Researchers successfully completed percutaneous ablation surgery using a robotic system. If there were no major needle adjustments during the procedure and no instrument defects or mechanical arm collisions occurred, the technique can be deemed successful.
Measured: Perioperative/Periprocedural
Secondary outcomes (8)
The proportion of cases where puncture is successful after one puncture or fine adjustment
Measured: Perioperative/Periprocedural
One technical success rate
A technical success is defined as the achievement of technical success with a single needle puncture or minor adjustments. One technical success rate is the percentage of technical success cases in the total number of cases.
Measured: Perioperative/Periprocedural
One-needle puncture placement rate
After the needle is inserted according to the pre-planned puncture direction, angle, and depth, a CT scan is performed to observe the positional relationship between the needle tip and the lung nodule. If the proposed ablation range at the needle tip position can surround the lung nodule by 5-10 mm, the researcher determines that no needle adjustment is necessary and that the ablation procedure can continue, thus confirming that the needle is in the correct position. The one-needle puncture success rate is the proportion of punctures that are successful on the first attempt.
Measured: Perioperative/Periprocedural
Complete ablation rate
By measuring whether the post-ablation GGO exceeds the pre-ablation GTR boundary by 5-10 mm on the post-ablation CT image, it is determined whether complete ablation has been achieved.
Measured: Perioperative/Periprocedural
Number of needle adjustments
Measured: Perioperative/Periprocedural
puncture duration
Measured: Perioperative/Periprocedural
Adverse event rate
Measured: Perioperative/Periprocedural
Incidence of device defects
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Lung AblationStudies of the same condition, open and under way.
- 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
- Xiaolong Yan, Dr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaolong Yan, Dr., Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105813
- Sponsor's protocol ID
- WD-2024SY-1001
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Safety and Efficacy of a Perforated Surgical Navigation and Localization System for Use in Percutaneous Pulmonary Ablation of Multiple Ground-glass Nodules
- ClinicalTrials.gov ID
- NCT07105813
- Acronym / sponsor ID
- WD-2024SY-1001
- Conditions
- Percutaneous Lung Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiaolong Yan, Dr.University, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
The purpose of the trial is to exploratively evaluate the safety and efficacy of the Puncture Surgery Navigation and Positioning System for CT-guided percutaneous lung ablation procedures for multiple ground glass nodules.
Thirty subjects are planned to be enrolled in this study. In the study, it is planned to perform CT-guided percutaneous lung ablation procedures in the enrolled patients using the Puncture Surgery Navigation and Positioning System, and to evaluate the technical success rate, puncture accuracy, one-time technical success rate, one-needle penetration in place, number of needle adjustments, time to puncture, and complication rate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigational Positioning System for Puncture Surgery | Experimental | Device: Navigational Positioning System for Puncture Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and <80 years, regardless of sex;
- Diagnosis of persistent multiple pulmonary ground glass nodules (GGN), including pure ground glass nodules (pGGN) and mixed ground glass nodules (mGGN), with no limitation on the size and number of nodules, where persistence is defined as the non-resolution of the GGN after 3 months of follow-up after detection;
- Patients who are evaluated as needing treatment for a primary or secondary lesion of a ground glass nodule in the lung, and the diameter of the lesion to be ablated is ≥6.0 mm, and who meet any of the following can be enrolled:
- The patient fully understands the benefits and risks of this trial, is willing to participate in the trial and signs an informed consent form.
Key exclusion criteria (16 listed)
- Those with skin redness, swelling, broken skin, symptoms of skin diseases at the puncture site, dermatologic diseases that cannot be affixed with markers, or acute suppurative infections in the pleural cavity;
- Platelets <50 × 109/L, or severe bleeding tendency, coagulation dysfunction that cannot be corrected in a short period of time (prothrombin time >18 s, plasminogen activity <40%), or anticoagulant therapy and/or antiplatelet drugs that have not been discontinued for more than 5 d to 7 d prior to ablation, and the interval between the last use of bevacizumab has not exceeded 1 month;
- Those with severe systemic infection and high fever (>38.5°C);
- Lung nodules close to important organs such as mediastinum or cardiac great vessels;
- Those who have other diseases such as pulmonary pustules or pulmonary cysts leading to pneumothorax in the proposed puncture path, or those who have obvious infectious lesions in the puncture path;
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 |
|---|---|---|
| Navigational Positioning System for Puncture SurgerySuitable for puncture surgery navigation and localization systems to assist in the procedure | Device | Navigational Positioning System for Puncture Surgery |
Primary outcome
Technical success rate
Time frame: Perioperative/Periprocedural
Researchers successfully completed percutaneous ablation surgery using a robotic system. If there were no major needle adjustments during the procedure and no instrument defects or mechanical arm collisions occurred, the technique can be deemed successful.
8 secondary outcomes
The proportion of cases where puncture is successful after one puncture or fine adjustment
Time frame: Perioperative/Periprocedural
One technical success rate
Time frame: Perioperative/Periprocedural
One-needle puncture placement rate
Time frame: Perioperative/Periprocedural
Complete ablation rate
Time frame: Perioperative/Periprocedural
Number of needle adjustments
Time frame: Perioperative/Periprocedural
puncture duration
Time frame: Perioperative/Periprocedural
Adverse event rate
Time frame: Perioperative/Periprocedural
Incidence of device defects
Time frame: Perioperative/Periprocedural
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 6 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Navigational Positioning System for Puncture Surgery in people with Percutaneous Lung Ablation, run by Xiaolong Yan, Dr..
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 10 inclusion and 16 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 6 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: Perioperative/Periprocedural). 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 6 Aug 2025.