Status:
NOT_YET_RECRUITING
RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Peripheral Pulmonary Nodules
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 bronchosc...
Detailed Description
This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 184 participants planned for enrollment. Subjects with peripheral pulmonary no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06962436
Start Date
May 1 2025
End Date
December 1 2026
Last Update
May 8 2025
Active Locations (5)
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1
Shandong Public Health Clinical Center
Jinan, Shandong, China, 250000
2
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
3
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
4
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200032