Robotic Bronchoscopy in Lung Cancer Diagnosis.
Vasileios S Skouras, Ioannis Gkiozos, Andriani G Charpidou...
https://pubmed.ncbi.nlm.nih.gov/38539514Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06613412
Feasibility and Safety of Remote Robotic Bronchoscopy System for Diagnosing Peripheral Pulmonary Lesions Using 5G Technology: A Multicenter, Proof-of-Concept Clinical Trial
Led by Guangzhou Medical University · Updated on 2024-11-22
10
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of a remote robotic bronchoscopy system supported by a 5G network to improve the diagnosis of peripheral pulmonary nodules. This trial aims to evaluate the safety and effectiveness of this technology in guiding biopsy sampling, addressing challenges in medical services especially in remote or underdeveloped areas. The study focuses on how 5G-enabled telemedicine and bronchoscopy integration can enhance diagnostic rates and standardize care for lung lesions. The trial is designed as a prospective, multicenter, single-group clinical study involving 10 patients with peripheral lung nodules. Participants will undergo airway examination and sampling using bronchial navigation and localization equipment operated remotely via a 5G network. Procedures include preoperative CT imaging for lesion localization, general anesthesia with ventilator support, and precise remote control of a mechanical arm to navigate the bronchoscope to the lesion for biopsy. Tissue samples will be collected and sent for immediate pathological analysis. Postoperative monitoring will track any adverse events related to the procedure or equipment. Participants will have chest CT scans before the procedure, followed by the biopsy conducted under general anesthesia with real-time remote control. Researchers will observe vital signs, collect tissue samples, and monitor for complications up to three days post-procedure. The study will measure equipment failure rates during bronchoscopy, network performance during operation, biopsy sampling yield, and incidence of adverse events within seven days after surgery. Data analysis will assess the feasibility and safety of using remote bronchoscopy aided by 5G technology for diagnosing peripheral lung lesions.
CONDITIONS
Brief 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
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Presence of a peripheral lung lesion on chest CT located in the fourth-order or higher airway
- Requires biopsy for diagnosis based on clinical and imaging assessment
- Willing to undergo bronchoscopy and biopsy procedures
- Able to understand the trial purpose, comply with examinations and follow-up, and provide informed consent
You will not qualify if you...
- Contraindications for bronchoscopy such as active massive hemoptysis, recent heart attack or unstable angina, severe heart or lung dysfunction, severe hypertension or arrhythmias, bleeding disorders, uremia, severe pulmonary hypertension, superior vena cava syndrome, intracranial hypertension, recent stroke, aortic dissection or aneurysm, multiple bullae, or extreme exhaustion
- Pregnant, breastfeeding, or planning pregnancy
- Have electromagnetic active implantable medical devices
- Allergic to anesthetics or have a history of severe allergies or hereditary allergies
- Participated in drug clinical trials within 3 months or medical device trials within 30 days
- Other conditions making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 to 2 days
Participants undergo chest CT scans to identify and locate peripheral pulmonary lesions and plan the biopsy route.
1 visit (in-person)
Implementation
Duration - 1 day
Participants undergo bronchoscopy and biopsy procedures using either a remote robotic bronchoscopy system with 5G support or a local robotic bronchoscopy system, including anesthesia and tissue sampling.
1 surgical procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 3 days after procedure
Participants are monitored for adverse events and recovery following the bronchoscopy and biopsy, including assessment of vital signs and possible complications.
1 to 2 visits depending on recovery
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510163
Actively Recruiting
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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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Published Research Related To This Trial
5G-Based Remote Virtual Bronchoscopic Navigation-Guided Transbronchial Lung Biopsy for Diagnosis of Lung Cancer: Description of 2 Cases.
Junfeng Huang, Jinsheng Lin, Chongxiang Chen...
https://pubmed.ncbi.nlm.nih.gov/37806300