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Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, proof-of Concept Trial

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial status changed: Unknown → Completed Show 6 more changesShow less
    • Final enrollment: 20 participants (planned 10)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description expanded, about 409 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknown
    • Primary completion date: Sep 15, 2024 to Dec 31, 2024
    • Study completion date: Oct 15, 2024 to Feb 15, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06613412
Lead Sponsor Guangzhou Medical University
Conditions
(from sponsor)		 Pulmonary Nodule
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov