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

NCT06613412 | Recruiting DMC

• 1 other identifier: ES-2024-063-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pulmonary Nodule

Keywords

peripheral pulmonary lesions; remote bronchoscopy; robotic bronchoscopy system

Outcome Measures

Primary Outcomes (1)

• equipment failure rate

  The equipment failure rate is calculated as (number of instances of equipment failure / total number of uses) x 100%. Equipment failures are defined as follows: 1. Network delays ≥ 200ms that persist for more than 3 seconds; 2. Any equipment malfunction that results in the cessation of surgery.

  During the bronchoscopy

Secondary Outcomes (5)

• Average Latency

  During the operation

• Bandwidth

  During the operation

• Network Incidents and Recovery Time

  During the operation

• Sampling yield

  7 days after bronchoscopy

• Incidence of Adverse Events

  7 days after operation

Other Outcomes (1)

• Diagnostic yield

  7 days after bronchoscopy

Study Arms (2)

5G group

EXPERIMENTAL

Biopsies of patients with pulmonary peripheral lesions (PPL) were performed using a remotely operated robotic bronchoscopy system supported by a 5G network.

Diagnostic Test: Remote Robotic Bronchoscopy system

local group

NO INTERVENTION

In the absence of 5G network support, a local robotic bronchoscopy system is utilized to perform biopsies on patients with pulmonary peripheral lesions (PPL).

Interventions

Remote Robotic Bronchoscopy system DIAGNOSTIC_TEST

Utilization of a remote robotic bronchoscopy system for the biopsy of patients with pulmonary peripheral lesions

5G group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from this study:
• 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.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510163, China

RECRUITING

Related Publications (2)

• Skouras VS, Gkiozos I, Charpidou AG, Syrigos KN. Robotic Bronchoscopy in Lung Cancer Diagnosis. Cancers (Basel). 2024 Mar 17;16(6):1179. doi: 10.3390/cancers16061179.

  PMID: 38539514 BACKGROUND

• Huang J, Lin J, Chen C, Liang W, Chen Y, Li H, Zhong C, Li S. 5G-Based Remote Virtual Bronchoscopic Navigation-Guided Transbronchial Lung Biopsy for Diagnosis of Lung Cancer: Description of 2 Cases. Respiration. 2023;102(10):912-917. doi: 10.1159/000533867. Epub 2023 Oct 6.

  PMID: 37806300 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: September 26, 2024
• Study Start: September 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 15, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)