An interventional study of Percutaneous Needle Biopsy with Interventional Surgical Control System and Conventional Manual Percutaneous Needle Biopsy in Pulmonary Nodules, Lung Cancer (Diagnosis) and Percutaneous Needle Biopsy, sponsored by Jiayuan Sun. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Jiayuan Sun · Not applicable, Interventional, and Diagnostic
This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 158 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Jiayuan Sun is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation.
Exclusion Criteria:
1) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, , emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic , severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo percutaneous needle biopsy of pulmonary nodules assisted by a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
Diagnostic Test: Percutaneous Needle Biopsy with Interventional Surgical Control System
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules, operated by experienced interventional physicians.
Diagnostic Test: Conventional Manual Percutaneous Needle Biopsy
Patients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
Also known as: Robotic assisted PTNB
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.
Also known as: Conventional PTNB
Dianostic yield
Malignant lesions and specific benign lesions (e.g., fungal infections, tuberculosis, granulomas, etc.) are considered as having a definitive diagnosis. Non-specific benign lesions (e.g., inflammation) are deemed diagnosed if they are confirmed by at least 6 months of follow-up, surgical resection, other biopsy methods, or radiological follow-up showing lesion shrinkage or disappearance. Atypical cells or normal lung tissue are classified as non-diagnostic.
Time frame: Up to 6 months after biopsy
Technical Success Rate
Defined as the successful positioning of the biopsy needle to the target lesion by the investigator based on intra-operative CT, without the use of other auxiliary puncture tools or needle guidance techniques. If yes, it is defined as technically successful. Technical success rate = (Number of patients with technical success / Total number of participants) × 100%.
Time frame: Intra-operative
Number of Needle Adjustments
The number of needle adjustments from the moment the first needle tip touches the skin until the researcher confirms the puncture is successful, recorded by the investigator during the procedure. Any change in puncture direction, needle withdrawal, or needle removal after needle insertion should be counted.
Time frame: Intra-operative
Puncture time
Refers to the duration from when the needle tip first reaches the skin puncture site to when successful puncture is confirmed (i.e., when the investigator judges that biopsy can be performed based on intra-operative CT scan).
Time frame: Intra-operative
Procedural Time
Refers to the total time from when the patient is positioned to when the procedure is completed.
Time frame: Intra-operative
Complication rate
Common complications of percutaneous needle biopsy include puncture site infection, pneumothorax, bleeding, hemoptysis, pleural reaction, etc. Rare complications include air embolism, cardiac tamponade, tumor seeding along the needle tract, nerve injury, etc.
Time frame: Up to 6 months after biopsy
Radiation dose
The radiation dose received by the patient as recorded by the CT scan protocol during the biopsy procedure
Time frame: Intra-operative
Plan to share: No
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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