Actively Recruiting
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial
Led by Guangzhou Medical University · Updated on 2024-11-22
10
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Robotic bronchoscopy represents the latest localization technology for peripheral pulmonary nodules, enabling precise and stable manipulation, thereby enhancing the diagnostic yield of peripheral lung pathologies. Its safety and feasibility have been internationally validated, with indications that it can significantly improve the overall diagnostic rate of biopsies for peripheral lung lesions. Nonetheless, the disparity in interventional auxiliary equipment and the level of technical operation is the primary cause for the significant variation in diagnostic rates of peripheral lung lesions across different regions, particularly in remote or underdeveloped areas. The advancement of 5G network technology has propelled the development of telemedicine, enabling remote diagnostics, surgeries, and real-time multi-party collaboration, which is expected to elevate the medical standards in remote areas, improve the diagnostic rate of peripheral lung lesions, and achieve homogenization of medical services. In summary, the integration of 5G with bronchoscopy is anticipated to bring breakthroughs in the diagnosis and treatment of peripheral lung pathologies. Research Objective: The primary objective of this clinical trial is to evaluate the safety and efficacy of the remote application of bronchoscopy systems and catheters for the localization and sampling of peripheral pulmonary nodules, under the premise of ensuring the safety of the subjects and the scientific integrity of the clinical trial, with the aid of 5G network. Research Method: The study is a prospective, multicenter, single-arm clinical trial with a target value design, intending to include 10 cases of individuals with peripheral pulmonary nodules who are willing to undergo intra-airway examination and sampling operations using remote bronchial navigation localization devices assisted by the 5G communication network. The safety and efficacy of the bronchial navigation localization devices and catheters for the localization and sampling of peripheral pulmonary nodules, developed by Changzhou Langhe Medical Devices Co., Ltd. (hereinafter referred to as "Langhe Medical"), will be assessed. Analysis: Statistical data analysis will be performed using SAS software version 9.4 or higher.
CONDITIONS
Official Title
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years, any gender
- Have a peripheral lung lesion located in the fourth-order or higher airway on chest CT
- Require biopsy as determined by clinical assessment including imaging and tumor markers
- Willing to undergo bronchoscopy and able to comply with study procedures and follow-up
- Able to understand the study purpose and provide informed consent
You will not qualify if you...
- Have contraindications for bronchoscopy such as active massive bleeding, recent heart attack or unstable angina, severe heart or lung dysfunction, severe hypertension or arrhythmias, severe coagulation disorders, uremia, severe pulmonary artery hypertension, severe superior vena cava syndrome, intracranial hypertension, acute stroke, aortic dissection or aneurysm, multiple lung bullae, or extreme exhaustion
- Are pregnant, breastfeeding, or planning pregnancy
- Have electromagnetic active implantable medical devices
- Are allergic to anesthetics or have a history of severe allergies
- Participated in drug clinical trials within 3 months or medical device trials within 30 days before screening
- Any other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510163
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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