Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613412
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions a Multicenter Randomized Controlled Proof-of Concept Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions a Multicenter Randomized Controlled Proof-of Concept Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 94 or higher
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 94 or higher
Detailed Description:
Study design
This study is a prospective multicenter single-group target value clinical trial intending to include 10 cases of peripheral pulmonary nodules who are willing to accept airway examination and sampling operations assisted by a remote bronchoscopy system under the 5G communication network The safety and efficacy of the bronchial navigation and localization equipment and catheter developed by Changzhou Langhe Medical Device Co Ltd hereinafter referred to as Langhe Medical for peripheral pulmonary nodule localization and sampling are evaluated
The detailed operation of using the bronchial navigation and localization equipment and catheter for peripheral pulmonary nodule localization and sampling is as follows
1 Conduct a network test before the experiment Both test sites connect in advance to ensure that the network signal at the operation site meets the requirements
2 Perform a chest CT examination on the patient import the CT data into the system mark the location of the target lesion and plan the route
3 Fasting for 6 hours before surgery and hydrating for 2 hours
4 During the surgery the patient is asked to lie flat with the neck slightly hyperextended Under general anesthesia the glottis is exposed using a laryngoscope and a tracheal intubation and ventilator-assisted ventilation are placed under direct vision The main controller operator assisted by the 5G network remotely controls the co-controllers mechanical arm to make the bronchial navigation and localization equipment and catheter hereinafter referred to as the catheter pass through the tracheal intubation to the carina for navigation registration After the registration is completed under the continuous view of the catheter and real-time positioning guidance precise control is achieved within the airway and the planned route is followed through various bronchi image collection is performed at each pulmonary segment opening and the target lesion location is reached according to real-time navigation data
5 When the lesion is visible under the field of view of the catheters front-end camera or when the co-controller operator confirms the arrival at the lesion through radial ultrasound via the catheters working channel after the researchers from both sites determine that the actual distance is sufficient to complete the biopsy sampling the co-controller operator will send biopsy forceps cell brushes and other instruments through the catheters working channel to complete the sampling by clamping and brushing
6 Each subject collects 5-8 tissue specimens which are processed for liquid-based cytology smears and pathology and all specimens are sent for immediate pathological examination
7 Postoperative follow-up to observe the occurrence of adverse events The operation process must strictly follow the relevant operation specifications and be carried out according to the product instructions of the corresponding equipment Accurate localization of the target pulmonary nodule close observation of vital signs presence of postoperative complications and adverse events related to the test equipment should be maintained Adverse events should be observed before dischargedischarge or within 3 days after the operation and if respiratory distress symptoms occur chest X-rays or other examinations should be conducted for confirmation
This study is a prospective multicenter single-group target value clinical trial intending to include 10 cases of peripheral pulmonary nodules who are willing to accept airway examination and sampling operations assisted by a remote bronchoscopy system under the 5G communication network The safety and efficacy of the bronchial navigation and localization equipment and catheter developed by Changzhou Langhe Medical Device Co Ltd hereinafter referred to as Langhe Medical for peripheral pulmonary nodule localization and sampling are evaluated
The detailed operation of using the bronchial navigation and localization equipment and catheter for peripheral pulmonary nodule localization and sampling is as follows
1 Conduct a network test before the experiment Both test sites connect in advance to ensure that the network signal at the operation site meets the requirements
2 Perform a chest CT examination on the patient import the CT data into the system mark the location of the target lesion and plan the route
3 Fasting for 6 hours before surgery and hydrating for 2 hours
4 During the surgery the patient is asked to lie flat with the neck slightly hyperextended Under general anesthesia the glottis is exposed using a laryngoscope and a tracheal intubation and ventilator-assisted ventilation are placed under direct vision The main controller operator assisted by the 5G network remotely controls the co-controllers mechanical arm to make the bronchial navigation and localization equipment and catheter hereinafter referred to as the catheter pass through the tracheal intubation to the carina for navigation registration After the registration is completed under the continuous view of the catheter and real-time positioning guidance precise control is achieved within the airway and the planned route is followed through various bronchi image collection is performed at each pulmonary segment opening and the target lesion location is reached according to real-time navigation data
5 When the lesion is visible under the field of view of the catheters front-end camera or when the co-controller operator confirms the arrival at the lesion through radial ultrasound via the catheters working channel after the researchers from both sites determine that the actual distance is sufficient to complete the biopsy sampling the co-controller operator will send biopsy forceps cell brushes and other instruments through the catheters working channel to complete the sampling by clamping and brushing
6 Each subject collects 5-8 tissue specimens which are processed for liquid-based cytology smears and pathology and all specimens are sent for immediate pathological examination
7 Postoperative follow-up to observe the occurrence of adverse events The operation process must strictly follow the relevant operation specifications and be carried out according to the product instructions of the corresponding equipment Accurate localization of the target pulmonary nodule close observation of vital signs presence of postoperative complications and adverse events related to the test equipment should be maintained Adverse events should be observed before dischargedischarge or within 3 days after the operation and if respiratory distress symptoms occur chest X-rays or other examinations should be conducted for confirmation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None