The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

November 30, 2025 updated by: Jiayuan Sun

A Prospective, Single-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of the Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent 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, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic assisted group
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 undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
Other Names:
  • Robotic assisted PTNB
Active Comparator: Manual group
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules, operated by experienced interventional physicians.
Diagnostic test: Conventional Manual Percutaneous Needle Biopsy
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.
Other Names:
  • Conventional PTNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dianostic yield
Time Frame: Up to 6 months after biopsy

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.
Up to 6 months after biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success Rate
Time Frame: Intra-operative
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%.
Intra-operative
Number of Needle Adjustments
Time Frame: Intra-operative
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.
Intra-operative
Puncture time
Time Frame: Intra-operative
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).
Intra-operative
Procedural Time
Time Frame: Intra-operative
Refers to the total time from when the patient is positioned to when the procedure is completed.
Intra-operative
Complication rate
Time Frame: Up to 6 months after biopsy
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.
Up to 6 months after biopsy
Radiation dose
Time Frame: Intra-operative
The radiation dose received by the patient as recorded by the CT scan protocol during the biopsy procedure
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiayuan Sun

Collaborators

Shanghai United Imaging Intelligence Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS25177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer (Diagnosis)

Clinical Trials on Percutaneous Needle Biopsy with Interventional Surgical Control System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe