Robotic-assisted bronchoscopy versus ultrathin bronchoscopy with virtual navigation for diagnosing peripheral lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized non-inferiority trial planning to enroll 186 adults with peripheral pulmonary nodules suspicious for malignancy who require non-surgical biopsy. Participants are randomly assigned to robotic-assisted bronchoscopy using a system developed by Changzhou Langhe Medical Devices or to ultrathin bronchoscopy guided by virtual bronchoscopic navigation, with radial endobronchial ultrasound (r-EBUS) available for all procedures. When the physician judges biopsy sampling feasible, a transbronchial lung biopsy will be performed during the procedure. The primary endpoint is an intermediate definition of diagnostic yield, and secondary endpoints include navigation success yield, time to lesion arrival, complication rates, and a strict diagnostic-yield definition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years, regardless of gender;
2. Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
3. Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
4. Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
2. Patients with pure ground-glass nodules suspected of malignancy on chest CT;
3. Female patients who are breastfeeding, pregnant, or planning pregnancy;
4. Patients with electromagnetic active implantable medical devices;
5. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
6. Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
7. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Where it's running

• Shandong Public Health Clinical Center
  Jinan, Shandong, China Recruiting
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Zhongshan Hospital，Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaoxuan Zheng
• Email: milozheng9140@163.com
• Phone: 18930859598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.