The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy

NCT07277088 | Not Yet Recruiting

• 1 other identifier: IS25177
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months after biopsy

Secondary Outcomes (6)

• Technical Success Rate

  Intra-operative

• Number of Needle Adjustments

  Intra-operative

• Puncture time

  Intra-operative

• Procedural Time

  Intra-operative

• Complication rate

  Up to 6 months after biopsy

Study Arms (2)

Robotic assisted group

EXPERIMENTAL

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

Manual group

ACTIVE COMPARATOR

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

Diagnostic Test: Conventional Manual Percutaneous Needle Biopsy

Interventions

Percutaneous Needle Biopsy with Interventional Surgical Control System 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.

Also known as: Robotic assisted PTNB

Robotic assisted group

Conventional Manual Percutaneous Needle Biopsy DIAGNOSTIC_TEST

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

Also known as: Conventional PTNB

Manual group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Jiayuan Sun: lead
• Shanghai United Imaging Intelligence Co., Ltd: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

Related Publications (9)

• Anzidei M, Argiro R, Porfiri A, Boni F, Anile M, Zaccagna F, Vitolo D, Saba L, Napoli A, Leonardi A, Longo F, Venuta F, Bezzi M, Catalano C. Preliminary clinical experience with a dedicated interventional robotic system for CT-guided biopsies of lung lesions: a comparison with the conventional manual technique. Eur Radiol. 2015 May;25(5):1310-6. doi: 10.1007/s00330-014-3508-z. Epub 2014 Nov 23.

  PMID: 25417130 RESULT

• Appelbaum L, Sosna J, Nissenbaum Y, Benshtein A, Goldberg SN. Electromagnetic navigation system for CT-guided biopsy of small lesions. AJR Am J Roentgenol. 2011 May;196(5):1194-200. doi: 10.2214/AJR.10.5151.

  PMID: 21512092 RESULT

• Alexander ES, Petre EN, Bodard S, Marinelli B, Sarkar D, Cornelis FH. Comparison of a Patient-Mounted Needle-Driving Robotic System versus Single-Rotation CT Fluoroscopy to Perform CT-Guided Percutaneous Lung Biopsies. J Vasc Interv Radiol. 2024 Jun;35(6):859-864. doi: 10.1016/j.jvir.2024.02.023. Epub 2024 Mar 5.

  PMID: 38447771 RESULT

• Lee KH, Lim KY, Suh YJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Yoon SH, Lee W, Park CM. Diagnostic Accuracy of Percutaneous Transthoracic Needle Lung Biopsies: A Multicenter Study. Korean J Radiol. 2019 Aug;20(8):1300-1310. doi: 10.3348/kjr.2019.0189.

  PMID: 31339018 RESULT

• Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.

  PMID: 23649436 RESULT

• Chang YY, Chen CK, Yeh YC, Wu MH. Diagnostic feasibility and safety of CT-guided core biopsy for lung nodules less than or equal to 8 mm: A single-institution experience. Eur Radiol. 2018 Feb;28(2):796-806. doi: 10.1007/s00330-017-5027-1. Epub 2017 Sep 7.

  PMID: 28884222 RESULT

• Horeweg N, van Rosmalen J, Heuvelmans MA, van der Aalst CM, Vliegenthart R, Scholten ET, ten Haaf K, Nackaerts K, Lammers JW, Weenink C, Groen HJ, van Ooijen P, de Jong PA, de Bock GH, Mali W, de Koning HJ, Oudkerk M. Lung cancer probability in patients with CT-detected pulmonary nodules: a prespecified analysis of data from the NELSON trial of low-dose CT screening. Lancet Oncol. 2014 Nov;15(12):1332-41. doi: 10.1016/S1470-2045(14)70389-4. Epub 2014 Oct 1.

  PMID: 25282285 RESULT

• Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.

  PMID: 26135833 RESULT

• Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.

  PMID: 39036382 RESULT

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiayuan Sun, PhD

CONTACT

86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)