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Recruiting NCT06962436

RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

No phase Interventional Peripheral Pulmonary Nodules

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic bronchoscopy system, Ultrathin bronchoscope combined with virtual bronchoscopic navigation.
Who it may be relevant to
Registry conditions: Peripheral Pulmonary Nodules. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study

Overview

The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.

Detailed description

This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.

Interventions

  • Device Robotic bronchoscopy system
    Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
  • Device Ultrathin bronchoscope combined with virtual bronchoscopic navigation
    Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

Primary outcome measures

  • Diagnostic yield [Time frame: 14 days post-procedure]
Secondary outcome measures (4)
  • Navigation success yield [Time frame: During the procedure]
  • Navigation time [Time frame: During the procedure]
  • Incidence of complications [Time frame: 14 days post-procedure]
  • Strict definition of diagnostic yield [Time frame: 14 days post-procedure]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years, regardless of gender;
  • Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
  • Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
  • 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

  • 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;
  • Patients with pure ground-glass nodules suspected of malignancy on chest CT;
  • Female patients who are breastfeeding, pregnant, or planning pregnancy;
  • Patients with electromagnetic active implantable medical devices;
  • Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
  • 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;
  • Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 5 centers
  • Shandong Public Health Clinical Center — Jinan
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
  • Shanghai Chest Hospital — Shanghai
  • Zhongshan Hospital，Fudan University — Shanghai
  • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06962436 · SHCHE202503

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗