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Pulmonary NoduleNCT06613412

Safety and Feasibility of Remote Robotic Bronchoscopy for Peripheral Lung Cancer: A Multicenter, Proof-of-concept Study

A study testing Remote Robotic Bronchoscopy system in people with Pulmonary Nodule, run by Guangzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Nodule
What is being tested?
Remote Robotic Bronchoscopy system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
15 Sep 2024to 15 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163

Other trials in China

About this study

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.

Read the detailed description

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 improve the overall diagnostic performance of biopsies for peripheral lung lesions. Nonetheless, disparities in interventional auxiliary equipment and the level of technical operation remain important causes of 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, remote operations, and real-time multi-party collaboration. The integration of 5G communication with robotic bronchoscopy may therefore provide a practical approach for remote delivery of advanced bronchoscopic expertise and may help reduce regional disparities in the diagnosis of peripheral pulmonary lesions.

Research Objective:

The primary objective of this clinical trial is to evaluate the safety and efficacy of the remote application of the bronchoscopy system and catheter for localization and sampling of peripheral pulmonary nodules with the aid of a 5G communication network. In addition, the study will explore the procedural performance, diagnostic yield, and safety outcomes of remote robotic bronchoscopy in comparison with conventional locally operated robotic bronchoscopy.

Research Method:

This study is a prospective, multicenter, parallel-group clinical trial involving 20 patients with peripheral pulmonary nodules who are willing to undergo bronchoscopic examination and sampling. Ten patients will be included in the remote group and will undergo localization and sampling using a remotely operated robotic bronchoscopy system assisted by the 5G communication network. The other 10 patients will be included in the local group and will undergo conventional locally operated robotic bronchoscopy using the same robotic bronchoscopy platform. 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 localization and sampling of peripheral pulmonary nodules will be assessed. Comparisons between the remote and local groups will be exploratory.

Analysis:

Statistical data analysis will be performed using SAS software version 9.4 or higher. Descriptive analyses will be conducted for demographic, lesion, procedural, network, diagnostic, and safety outcomes. Comparisons between the remote and local groups will be performed on an exploratory basis.

Study design This study is a prospective, multicenter, parallel-group clinical trial involving 20 patients with peripheral pulmonary nodules who are willing to accept airway examination and sampling procedures using a robotic bronchoscopy system. Ten patients will undergo 5G-assisted remote robotic bronchoscopy (remote group), and 10 patients will undergo conventional locally operated robotic bronchoscopy (local group). The bronchial navigation and localization equipment and catheter developed by Changzhou Langhe Medical Device Co., Ltd. (hereinafter referred to as "Langhe Medical") will be used for peripheral pulmonary nodule localization and sampling.

The detailed operation of using the bronchial navigation and localization equipment and catheter for peripheral pulmonary nodule localization and sampling is as follows:

  1. Before each procedure, equipment and system status will be checked. For the remote group, both test sites will connect in advance to conduct a network test and confirm that the network signal and remote-control system meet the procedural requirements.
  2. A chest CT examination will be performed before the procedure. CT data will be imported into the robotic bronchoscopy system, the target lesion will be marked, and the navigation route will be planned.
  3. Patients will fast for 6 hours before the procedure and refrain from drinking for 2 hours before the procedure.
  4. During the procedure, the patient will be placed in the supine position with the neck slightly extended. Under general anesthesia, endotracheal intubation and ventilator-assisted ventilation will be established. In the remote group, the master-unit operator will remotely control the slave-unit robotic arm through the 5G network, advance the catheter through the endotracheal tube to the carina, complete navigation registration, and navigate along the planned route toward the target lesion under continuous endoscopic visualization and real-time navigation guidance. In the local group, registration and robotic navigation will be performed locally using the same robotic bronchoscopy platform.
  5. When the target lesion is reached, lesion localization may be confirmed using radial endobronchial ultrasound through the working channel. In the remote group, the on-site operator will perform lesion confirmation and tissue sampling after the master- and slave-unit investigators determine that the catheter position is suitable for biopsy. In the local group, lesion confirmation and tissue sampling will be completed locally using the same procedural strategy. Biopsy forceps, cytology brushes, or other sampling instruments may be introduced through the catheter working channel as clinically appropriate.
  6. Approximately 5-8 tissue specimens will be collected from each subject when clinically appropriate. Specimens will be processed for liquid-based cytology, smears, and/or histopathological examination according to routine clinical practice.
  7. Postoperative follow-up will be conducted to observe adverse events. Particular attention will be paid to complications related to the procedure or study equipment. Adverse events will be observed before discharge or within 3 days after the procedure. If respiratory distress or other clinically significant symptoms occur, chest radiography or other appropriate examinations will be performed for further evaluation.

The operation process must strictly follow relevant procedural specifications and the instructions for use of the corresponding equipment. Accurate localization of the target pulmonary nodule, close monitoring of vital signs, postoperative complications, and adverse events related to the study equipment should be maintained throughout the study.

Being tested
Remote Robotic Bronchoscopy system
Keywords
peripheral pulmonary lesions, remote bronchoscopy, robotic bronchoscopy system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Robotic Bronchoscopy systemDiagnostic test

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

Study groups in NCT06613412
Study groupRoleWhat they receive
5G groupExperimentalBiopsies of patients with pulmonary peripheral lesions (PPL) were performed using a remotely operated robotic bronchoscopy system supported by a 5G network.
Receives: Diagnostic Test: Remote Robotic Bronchoscopy system
local groupNo interventionIn the absence of 5G network support, a local robotic bronchoscopy system is utilized to perform biopsies on patients with pulmonary peripheral lesions (PPL).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the bronchoscopy

Secondary outcomes (5)
  1. Average Latency

    Refers to the network data transmission delay, recording the continuous latency data from the start of registration to the end of sampling, and documenting the average, peak, and minimum values.

    Measured: During the operation

  2. Bandwidth

    Refers to the network transmission rate, recording the network bandwidth from the start of registration to the end of sampling at both control ends, documenting the maximum upload and download bandwidth.

    Measured: During the operation

  3. Network Incidents and Recovery Time

    Records the specific incidents and quantities of network interruptions and individual stutters >10 seconds during a single operation.

    Measured: During the operation

  4. Sampling yield

    Sampling yield = (Total number of cases with non-normal lung tissue obtained by biopsy sampling / Total number of cases undergoing biopsy sampling) × 100%. Note: Definitive sampling includes biopsy pathological results indicating cells/tissues as malignant, benign lesions (such as fungi, tuberculosis, or sarcoidosis, etc.), and non-normal lung tissue that cannot be confirmed.

    Measured: 7 days after bronchoscopy

  5. Incidence of Adverse Events

    Incidence of Adverse Events= (Number of cases with adverse events / Total number of sampled cases) × 100%

    Definitive adverse events includes: (1) any type of pneumothorax, irrespective of the necessity for tube thoracostomy, (2) bleeding during bronchoscopy requiring intervention, and (3) other adverse events such as fever, pain, and cough.

    Measured: 7 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start15 Sep 2024
  3. Primary completion31 Dec 2024
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06613412
Sponsor's protocol ID
ES-2024-063-01
Status last verified
Jul 2024
First submitted
6 Jul 2024
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38539514
  • 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.

    PubMed 37806300

Questions about this trial

What is this clinical trial studying?

A study testing Remote Robotic Bronchoscopy system in people with Pulmonary Nodule, run by Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

equipment failure rate (time frame: During the bronchoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06613412, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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