Pulmonary NoduleNCT06701448
Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions
A study testing robotic bronchosopy, Electromagnetic Navigation Bronchoscopy and Fluoroscopy bronchoscopy in people with Pulmonary Nodule and Bronchoscopy, run by Guangzhou Medical University at 1 site in China.
Trial summary
Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Nodule, Bronchoscopy
- What is being tested?
- robotic bronchosopy, Electromagnetic Navigation Bronchoscopy and Fluoroscopy bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2023
- 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
- 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:
- 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;
- Female patients who are breastfeeding, pregnant, or planning pregnancy;
- Patients with electromagnetic active implantable medical devices;
- Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
- 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;
- 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
Guangzhou, Guangdong, 510163
About this study
Official title: Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions: a Prospective, Multi-center, Parallel-Controlled Trial
Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB).
Read the detailed description
Pulmonary peripheral lesions (PPLs) are a prevalent medical condition and a significant contributory factor to the widespread health and social issues associated with pulmonary diseases, particularly lung cancer. In China, lung cancer has become the most common cancer in terms of new cases and deaths, with 1,060,600 new cases and 736,600 deaths recorded. Early diagnosis of PPLs is essential to prevent their progression to cancer.
Fluoroscopy bronchoscopy (FB) was previously the primary diagnostic method for PPLs. However, its limitation lies in the occurrence of adverse events, particularly pneumothorax. Furthermore, many patients are not suitable for percutaneous biopsy which has led to the exploration of alternative methods for diagnosis.
With the advancement of bronchoscopy, several innovative technologies have been proposed and developed for sampling tissues from PPLs in recent years. Electromagnetic navigation bronchoscopy (ENB) stands out as one of the most superior among them. Its integration of real-time guidance and precise maneuverability of a biopsy instrument gives it an advantage over alternative technologies.
The Robotic Bronchoscopy System (RBS) offers an excellent alternative method with enhanced flexibility and stability. The bronchoscopist is able to control the insertion and biopsy of the RBS from a console located near the patient, allowing for a more stable posture to access the distal airway compared to conventional bronchoscopy. Numerous studies have demonstrated that RBS exhibits an excellent navigation success rate and diagnosis rate. A multi-center study on the ION endoluminal platform (Intuitive Surgical, Inc.) revealed a navigation yield as high as 98.7% and a total diagnostic yield of 81.7%. Similarly, research on the Monarch RAB showed navigation yield and diagnostic yield of 96.2% and 74.1%, respectively.
The iLung Infinity system (LungHealth MedTech Ltd, Shanghai, China) is specifically designed to utilize real-time electromagnetic technology in order to localize and guide bronchoscopic tools towards the lesion on a pre-constructed three-dimensional bronchial tree.
The Unicorn Kylin™ robotic system represents a novel Robotic Bronchoscopy System (RBS). The system comprises an unit with two mechanical arms boasting nine degrees of freedom, a flexible bronchoscope (outer diameter: 4.3 mm; Working channel: 2.0 mm), and a console equipped with electromagnetic navigation system.
In the clinical setting, different sampling methods have a crucial impact on the quality of tissue samples and the treatment of patients. However, there are currently no existing studies that directly compare the diagnostic performance of RBS, ENB, and FB using the same definition of diagnostic yield in a homogenous patient population. It is imperative to gather comparative effectiveness data on these systems in order to develop an optimal strategy for patient care. Therefore, this study aimed to assess the diagnostic performance of RBS, ENB, and FB when conducting peripheral pulmonary biopsies. To achieve this goal, a multicenter controlled study was conducted across six medical centers or hospitals.
- Conditions
- Pulmonary Nodule, Bronchoscopy
- Being tested
- robotic bronchosopy, Electromagnetic Navigation Bronchoscopy, Fluoroscopy bronchoscopy
- Keywords
- peripheral pulmonary lesions, optimal strategy, robotic bronchocospy, electromagnetic navigation bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic bronchosopyDiagnostic test
robotic bronchoscopy
Electromagnetic Navigation BronchoscopyDiagnostic test
Electromagnetic Navigation Bronchoscopy
Fluoroscopy bronchoscopyDiagnostic test
Fluoroscopy bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| RBS group | Other | Biopsy of peripheral pulmonary lesions using RBS Receives: Diagnostic Test: robotic bronchosopy |
| ENB group | Other | Biopsy of peripheral pulmonary lesions using ENB Receives: Diagnostic Test: Electromagnetic Navigation Bronchoscopy |
| FB group | Other | Biopsy of peripheral pulmonary lesions using FB Receives: Diagnostic Test: Fluoroscopy bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic yield
Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.
Measured: 1 years after biopsy
Secondary outcomes (1)
Strict diagnostic yield
The secondary outcome of interest was the strict diagnostic yield, which is defined as the proportion of cases diagnosed with bronchoscopy pathology divided by all cases sampled using a specific technology. The bronchoscopy pathology diagnosis only included malignant and specific benign lesions.
Measured: 7 days after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Apr 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyue, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701448
- Sponsor's protocol ID
- EC-2022-037 (QX)-02
- Status last verified
- Jan 2019
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions: a Prospective, Multi-center, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT06701448
- Acronym / sponsor ID
- EC-2022-037 (QX)-02
- Conditions
- Pulmonary Nodule, Bronchoscopy
- Keywords
- peripheral pulmonary lesions, optimal strategy, robotic bronchocospy, electromagnetic navigation bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB).
Detailed description
Pulmonary peripheral lesions (PPLs) are a prevalent medical condition and a significant contributory factor to the widespread health and social issues associated with pulmonary diseases, particularly lung cancer. In China, lung cancer has become the most common cancer in terms of new cases and deaths, with 1,060,600 new cases and 736,600 deaths recorded. Early diagnosis of PPLs is essential to prevent their progression to cancer.
Fluoroscopy bronchoscopy (FB) was previously the primary diagnostic method for PPLs. However, its limitation lies in the occurrence of adverse events, particularly pneumothorax. Furthermore, many patients are not suitable for percutaneous biopsy which has led to the exploration of alternative methods for diagnosis.
With the advancement of bronchoscopy, several innovative technologies have been proposed and developed for sampling tissues from PPLs in recent years. Electromagnetic navigation bronchoscopy (ENB) stands out as one of the most superior among them. Its integration of real-time guidance and precise maneuverability of a biopsy instrument gives it an advantage over alternative technologies.
The Robotic Bronchoscopy System (RBS) offers an excellent alternative method with enhanced flexibility and stability. The bronchoscopist is able to control the insertion and biopsy of the RBS from a console located near the patient, allowing for a more stable posture to access the distal airway compared to conventional bronchoscopy. Numerous studies have demonstrated that RBS exhibits an excellent navigation success rate and diagnosis rate. A multi-center study on the ION endoluminal platform (Intuitive Surgical, Inc.) revealed a navigation yield as high as 98.7% and a total diagnostic yield of 81.7%. Similarly, research on the Monarch RAB showed navigation yield and diagnostic yield of 96.2% and 74.1%, respectively.
The iLung Infinity system (LungHealth MedTech Ltd, Shanghai, China) is specifically designed to utilize real-time electromagnetic technology in order to localize and guide bronchoscopic tools towards the lesion on a pre-constructed three-dimensional bronchial tree.
The Unicorn Kylin™ robotic system represents a novel Robotic Bronchoscopy System (RBS). The system comprises an unit with two mechanical arms boasting nine degrees of freedom, a flexible bronchoscope (outer diameter: 4.3 mm; Working channel: 2.0 mm), and a console equipped with electromagnetic navigation system.
In the clinical setting, different sampling methods have a crucial impact on the quality of tissue samples and the treatment of patients. However, there are currently no existing studies that directly compare the diagnostic performance of RBS, ENB, and FB using the same definition of diagnostic yield in a homogenous patient population. It is imperative to gather comparative effectiveness data on these systems in order to develop an optimal strategy for patient care. Therefore, this study aimed to assess the diagnostic performance of RBS, ENB, and FB when conducting peripheral pulmonary biopsies. To achieve this goal, a multicenter controlled study was conducted across six medical centers or hospitals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBS group | Other | Diagnostic Test: robotic bronchosopyBiopsy of peripheral pulmonary lesions using RBS |
| ENB group | Other | Diagnostic Test: Electromagnetic Navigation BronchoscopyBiopsy of peripheral pulmonary lesions using ENB |
| FB group | Other | Diagnostic Test: Fluoroscopy bronchoscopyBiopsy of peripheral pulmonary lesions using FB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are eligible for inclusion if they meet all of the following criteria:
Key exclusion criteria (7 listed)
- Patients who meet any of the following criteria will be excluded from this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic bronchosopyrobotic bronchoscopy | Diagnostic test | RBS group |
| Electromagnetic Navigation BronchoscopyElectromagnetic Navigation Bronchoscopy | Diagnostic test | ENB group |
| Fluoroscopy bronchoscopyFluoroscopy bronchoscopy | Diagnostic test | FB group |
Primary outcome
Overall diagnostic yield
Time frame: 1 years after biopsy
Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.
1 secondary outcome
Strict diagnostic yield
Time frame: 7 days after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 38539514Skouras 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic bronchosopy, Electromagnetic Navigation Bronchoscopy and Fluoroscopy bronchoscopy in people with Pulmonary Nodule and Bronchoscopy, 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 5 inclusion and 7 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 25 Nov 2024. 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?
Overall diagnostic yield (time frame: 1 years after biopsy). 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 NCT06701448, which also lists 1 linked publication.
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 25 Nov 2024.