Trial Title:
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial
NCT ID:
NCT06613412
Condition:
Pulmonary Nodule
Conditions: Official terms:
Multiple Pulmonary Nodules
Conditions: Keywords:
peripheral pulmonary lesions
remote bronchoscopy
robotic bronchoscopy system
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Remote Robotic Bronchoscopy system
Description:
Utilization of a remote robotic bronchoscopy system for the biopsy of patients with
pulmonary peripheral lesions
Arm group label:
5G group
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.
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-controller's 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 catheter's front-end
camera, or when the co-controller operator confirms the arrival at the lesion
through radial ultrasound via the catheter's 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 catheter's 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
discharge/discharge or within 3 days after the operation, and if respiratory
distress symptoms occur, chest X-rays or other examinations should be conducted for
confirmation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients are eligible for inclusion if they meet all of the following criteria:
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.
- Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from this study:
1.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.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510163
Country:
China
Status:
Recruiting
Contact:
Last name:
Changhao Zhong
Phone:
+86 13570290214
Email:
vast1982@126.com
Start date:
September 15, 2024
Completion date:
October 15, 2024
Lead sponsor:
Agency:
Guangzhou Medical University
Agency class:
Other
Source:
Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613412
