Pulmonary NodulesNCT07714629
Robot-Assisted Versus Manual Puncture for Pulmonary Nodule Ablation
An observational study of Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 26 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients with peripheral pulmonary nodules who underwent CT-guided thermal ablation at the First Affiliated Hospital of Guangzhou Medical University. Participants received either robot-assisted or conventional manual puncture according to routine clinical practice.
Who may be able to join
- Age ≥18 years.
- Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation.
- Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice.
- Written informed consent provided.
Who cannot join
- Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures.
- Previous thoracic surgery or local treatment affecting puncture planning.
- Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation.
- Pregnancy.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study
Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. This prospective observational cohort study aims to compare robot-assisted and conventional manual CT-guided puncture techniques for pulmonary nodule ablation. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture accuracy, radiation exposure, and procedure-related complications. The results will provide evidence regarding the clinical effectiveness and safety of robot-assisted puncture in pulmonary nodule ablation.
Read the detailed description
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety.
This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization.
The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses.
The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
- Conditions
- Pulmonary Nodules
- Keywords
- Pulmonary Nodules, Robot-Assisted Puncture, CT-Guided Ablation, Robotic Navigation, Thermal Ablation, Cryoablation
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Puncture | Patients undergoing CT-guided pulmonary nodule ablation using the TH-S1 robotic navigation system. | |
| Manual Puncture | Patients undergoing conventional manual CT-guided pulmonary nodule ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Needle Adjustments
Total number of needle adjustments required to achieve the planned puncture trajectory.
Measured: During the procedure
Number of Intraoperative CT Scans
Total number of CT scans performed during the puncture procedure.
Measured: During the procedure
Secondary outcomes (4)
Technical Success Rate
Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure.
Measured: During the procedure
Puncture Deviation
Puncture deviation was measured as the distance (mm) between the planned target point and the actual needle tip position after puncture.
Measured: During the procedure
Radiation Exposure
Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure.
Measured: During the procedure
Procedure-Related Complications
Procedure-related complications were evaluated and graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system.
Measured: Within 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start12 Dec 2024
- Primary completion24 Jun 2025
- Study completion26 Jun 2025
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 The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714629
- Sponsor's protocol ID
- ES-2024-129-02A
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07714629
- Acronym / sponsor ID
- ES-2024-129-02A
- Conditions
- Pulmonary Nodules
- Keywords
- Pulmonary Nodules, Robot-Assisted Puncture, CT-Guided Ablation, Robotic Navigation, Thermal Ablation, Cryoablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 20 Jul 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.
Pulmonary nodule ablation is an established minimally invasive treatment for selected patients with pulmonary nodules. Accurate puncture is critical for procedural efficiency and safety. This prospective observational cohort study aims to compare robot-assisted and conventional manual CT-guided puncture techniques for pulmonary nodule ablation. The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture accuracy, radiation exposure, and procedure-related complications. The results will provide evidence regarding the clinical effectiveness and safety of robot-assisted puncture in pulmonary nodule ablation.
Detailed description
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety.
This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization.
The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses.
The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Puncture | – | –Patients undergoing CT-guided pulmonary nodule ablation using the TH-S1 robotic navigation system. |
| Manual Puncture | – | –Patients undergoing conventional manual CT-guided pulmonary nodule ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with peripheral pulmonary nodules who underwent CT-guided thermal ablation at the First Affiliated Hospital of Guangzhou Medical University. Participants received either robot-assisted or conventional manual puncture according to routine clinical practice.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation.
- Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice.
- Written informed consent provided.
Key exclusion criteria (5 listed)
- Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures.
- Previous thoracic surgery or local treatment affecting puncture planning.
- Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation.
- Pregnancy.
- Inability or unwillingness to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Needle Adjustments
Time frame: During the procedure
Total number of needle adjustments required to achieve the planned puncture trajectory.
Number of Intraoperative CT Scans
Time frame: During the procedure
Total number of CT scans performed during the puncture procedure.
4 secondary outcomes
Technical Success Rate
Time frame: During the procedure
Puncture Deviation
Time frame: During the procedure
Radiation Exposure
Time frame: During the procedure
Procedure-Related Complications
Time frame: Within 48 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Needle Adjustments (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 20 Jul 2026.