Lung NodulesNCT07055997
Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study
A study testing Robotic-assisted needle localization and Manual needle localization in people with Lung Nodules and Lung Cancer (Diagnosis), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Nodules, Lung Cancer (Diagnosis), Robotic-Assisted Navigation System
- What is being tested?
- Robotic-assisted needle localization and Manual needle localization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Mar 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Ⅰ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (Ⅱ) the presence of pure ground-glass opacity (GGO) or mixed GGO (solid to tumor ratio < 0.5) on CT with clinical or radiological suspicion of malignancy; (Ⅲ) patient with a peripheral nodule, located in the outer third of the lung parenchyma, with its edge situated at least 5 mm away from the pleural surface; (Ⅳ) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention.
Who cannot join
- (Ⅰ) nodule location obstructed by the scapula, precluding needle access; (Ⅱ) proximity of the nodule to major blood vessels, defined as within 2 cm; (Ⅲ) requirement for localization of multiple pulmonary nodules.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: The Effectiveness of Robotic-assisted Navigation System for Preoperative Lung Nodule Localization: a Prospective, Single-center, Non-inferiority Clinical Study
This study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates.
Read the detailed description
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a robotic-assisted navigation system for lung nodule localization compared to traditional manual CT-guided needle localization. The study will be conducted between June 2024 and December 2024, involving 100 patients with lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or robotic-assisted needle localization. The primary outcome measure will be the localization success rate, defined as the ability to accurately locate the nodule and guide the needle to the target site for biopsy or surgery. Secondary outcome measures will include procedural duration, the number of CT scans required, total dose-length product (DLP), first-pass success rate, localization success within a single needle adjustment, and complication rate.
- Being tested
- Robotic-assisted needle localization, Manual needle localization
- Keywords
- Robotic-assisted, lung nodule, preoperative localization, video-assisted thoracoscopic surgery (VATS), non-inferiority study
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted needle localizationDevice
Robot-assisted needle localization involves the use of a robotic system to assist with the percutaneous localization of pulmonary nodules under CT guidance. The robotic system provides real-time navigation and increased precision during needle placement, reducing the variability in positioning and improving the accuracy of localization. The system offers automatic adjustments to the needle's trajectory, minimizing the need for manual corrections, and potentially reducing the number of CT scans required. This method is designed to enhance the overall localization success rate and reduce complications associated with traditional manual techniques.
Manual needle localizationProcedure or surgery
Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance without the assistance of robotic systems. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization.
| Study group | Role | What they receive |
|---|---|---|
| Freehand group | Active comparator | Manual CT-guided percutaneous needle localization of pulmonary nodules Receives: Procedure: Manual needle localization |
| Robotic group | Experimental | Robotic-assisted CT-guided percutaneous needle localization of pulmonary nodules Receives: Device: Robotic-assisted needle localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization Success Rate
The accuracy of nodule localization was designated as the primary outcome of the study. Successful localization was defined as a distance of less than 10 mm between the needle tip and the center of the nodule, with no displacement of the localization device between localization and surgery.
Measured: Immediately after needle localization and before surgery
Secondary outcomes (5)
Procedure Duration
Procedure duration was calculated from the time the patient was positioned on the CT scanner to the confirmation of successful needle insertion via the final CT scan.
Measured: From patient positioning on the CT scanner to confirmation of successful needle insertion via final CT scan
Number of CT Scans Required for Localization
The number of CT scans needed to successfully localize the nodule.
Measured: During the localization procedure
Total Dose-Length Product (DLP)
The total dose-length product (DLP) accumulated during the localization process.
Measured: During the localization procedure
First-pass Success Rate
First-pass success was defined as the successful localization of the nodule with the first needle insertion, without requiring any needle adjustment.
Measured: Immediately after the first needle insertion
Localization Success Rate within One Needle Adjustment
The localization success rate within one needle adjustment was defined as successful localization achieved after a single adjustment to the needle's depth or angle following initial misplacement.
Measured: Immediately after one needle adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- 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
- NCT07055997
- Sponsor's protocol ID
- ES-2024-129-02
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Robotic-assisted Navigation System for Preoperative Lung Nodule Localization: a Prospective, Single-center, Non-inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT07055997
- Acronym / sponsor ID
- ES-2024-129-02
- Keywords
- Robotic-assisted, lung nodule, preoperative localization, video-assisted thoracoscopic surgery (VATS), non-inferiority study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Jul 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.
This study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates.
Detailed description
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a robotic-assisted navigation system for lung nodule localization compared to traditional manual CT-guided needle localization. The study will be conducted between June 2024 and December 2024, involving 100 patients with lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or robotic-assisted needle localization. The primary outcome measure will be the localization success rate, defined as the ability to accurately locate the nodule and guide the needle to the target site for biopsy or surgery. Secondary outcome measures will include procedural duration, the number of CT scans required, total dose-length product (DLP), first-pass success rate, localization success within a single needle adjustment, and complication rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freehand group | Active comparator | Procedure: Manual needle localizationManual CT-guided percutaneous needle localization of pulmonary nodules |
| Robotic group | Experimental | Device: Robotic-assisted needle localizationRobotic-assisted CT-guided percutaneous needle localization of pulmonary nodules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (Ⅰ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (Ⅱ) the presence of pure ground-glass opacity (GGO) or mixed GGO (solid to tumor ratio < 0.5) on CT with clinical or radiological suspicion of malignancy; (Ⅲ) patient with a peripheral nodule, located in the outer third of the lung parenchyma, with its edge situated at least 5 mm away from the pleural surface; (Ⅳ) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention.
Key exclusion criteria (1 listed)
- (Ⅰ) nodule location obstructed by the scapula, precluding needle access; (Ⅱ) proximity of the nodule to major blood vessels, defined as within 2 cm; (Ⅲ) requirement for localization of multiple pulmonary nodules.
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 |
|---|---|---|
| Robotic-assisted needle localizationRobot-assisted needle localization involves the use of a robotic system to assist with the percutaneous localization of pulmonary nodules under CT guidance. The robotic system provides real-time navigation and increased precision during needle placement, reducing the variability in positioning and improving the accuracy of localization. The system offers automatic adjustments to the needle's trajectory, minimizing the need for manual corrections, and potentially reducing the number of CT scans required. This method is designed to enhance the overall localization success rate and reduce complications associated with traditional manual techniques. | Device | Robotic group |
| Manual needle localizationManual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance without the assistance of robotic systems. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization. | Procedure or surgery | Freehand group |
Primary outcome
Localization Success Rate
Time frame: Immediately after needle localization and before surgery
The accuracy of nodule localization was designated as the primary outcome of the study. Successful localization was defined as a distance of less than 10 mm between the needle tip and the center of the nodule, with no displacement of the localization device between localization and surgery.
5 secondary outcomes
Procedure Duration
Time frame: From patient positioning on the CT scanner to confirmation of successful needle insertion via final CT scan
Number of CT Scans Required for Localization
Time frame: During the localization procedure
Total Dose-Length Product (DLP)
Time frame: During the localization procedure
First-pass Success Rate
Time frame: Immediately after the first needle insertion
Localization Success Rate within One Needle Adjustment
Time frame: Immediately after one needle adjustment
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 9 Jul 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. 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?
A study testing Robotic-assisted needle localization and Manual needle localization in people with Lung Nodules and Lung Cancer (Diagnosis), 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 1 inclusion and 1 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 9 Jul 2025. 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?
Localization Success Rate (time frame: Immediately after needle localization and before surgery). 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 9 Jul 2025.