The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

NCT ID: NCT07277088

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-05-30

Brief Summary

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.

Conditions

Pulmonary Nodules; Lung Cancer (Diagnosis); Percutaneous Needle Biopsy; Transthoracic Needle Biopsy; Robotic Assisted Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Percutaneous Needle Biopsy with Interventional Surgical Control System

Intervention Type: DIAGNOSTIC_TEST

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.

Manual group

Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules, operated by experienced interventional physicians.

Group Type: ACTIVE_COMPARATOR

Conventional Manual Percutaneous Needle Biopsy

Intervention Type: DIAGNOSTIC_TEST

Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Robotic assisted PTNB; Conventional PTNB

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai United Imaging Intelligence Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Jiayuan Sun

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Countries

China

Central Contacts

Jiayuan Sun, PhD

Role: CONTACT

jysun1976@163.com

86-021-22200000

Facility Contacts

Jiayuan Sun, PhD

Role: primary

jysun1976@163.com

86-021-22200000

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Other Identifiers

IS25177

Identifier Type: -

Identifier Source: org_study_id