NCT06613412Completed
Safety and Feasibility of Remote Robotic Bronchoscopy for Peripheral Lung Cancer: A Multicenter, Proof-of-concept Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
Robotic bronchoscopy represents the latest localization technology for peripheral pulmonary nodules, enabling precise and stable manipulation and potentially improving the diagnostic yield of peripheral lung pathologies. Its safety and feasibility have been validated in previous studies. Nonetheless, disparities in interventional equipment and technical expertise remain important contributors to regional variation in the diagnostic performance of peripheral lung lesion biopsy, particularly in remote or underdeveloped areas. The advancement of fifth-generation (5G) network technology has promoted the development of telemedicine by enabling remote operation, real-time communication, and multi-site collaboration. Integration of 5G communication with robotic bronchoscopy may therefore provide a new approach to extend advanced bronchoscopic expertise across geographically separated medical centers. This prospective, multicenter clinical study will include 20 patients with peripheral pulmonary nodules or lesions requiring bronchoscopic localization and sampling. Ten patients will undergo 5G-assisted remote robotic bronchoscopy (remote group), and 10 patients will undergo conventional locally operated robotic bronchoscopy using the same robotic bronchoscopy platform (local group). The study will evaluate the safety and efficacy of remote robotic bronchoscopy and explore its procedural and diagnostic performance in comparison with local robotic bronchoscopy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 6 Jul 2024
- Start date
- 15 Sept 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06613412
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 15 Sept 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.Female patients who are breastfeeding, pregnant, or planning pregnancy; 3.Patients with electromagnetic active implantable medical devices; 4.Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history; 5.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; 6.Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Other
- Patients who meet any of the following criteria will be excluded from this study:
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Who the study is looking for
- Patients are eligible for inclusion if they meet all of the following criteria:
- Age ≥18 years and ≤75 years, with no gender restrictions; Presence of a peripheral lung lesion on chest CT [Peripheral lung is defined as a nodule located in the fourth-order or higher airway (with the carina defined as order 0, the left and right main bronchi defined as order 1, lobar bronchi as order 2, segmental bronchi as order 3, and subsegmental bronchi as order 4)] in patients who require biopsy [2. The population requiring biopsy refers to individuals identified with an occupational lung lesion/nodule (including solid nodules, part-solid nodules, and ground-glass nodules) during clinical trial screening or with risk factors, and who, after comprehensive assessment by a clinician of the patient's clinical information, imaging, tumor markers, and functional imaging, are highly suspected of having cancerous nodules. Bronchoscopy biopsy is planned to further clarify the diagnosis and to guide staging treatment based on pathological results.]; Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure; Patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.
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Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.