Remote robotic bronchoscopy for diagnosing lung nodules
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept Trial
This study is testing a new robotic system that helps doctors check for lung nodules more safely and effectively, especially in places where advanced medical technology is hard to reach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06613412 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and safety of a remote robotic bronchoscopy system for diagnosing peripheral pulmonary lesions. It involves a multicenter approach where patients with suspected lung nodules undergo a bronchial examination and sampling using advanced robotic technology facilitated by a 5G network. The study aims to enhance the diagnostic yield of biopsies for peripheral lung lesions, particularly in remote areas where access to advanced medical technology may be limited. Participants will be monitored for safety and efficacy throughout the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with peripheral lung lesions identified on chest CT who require a biopsy.
Not a fit: Patients with lung lesions that do not require biopsy or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the diagnostic rates of lung nodules, leading to earlier and more accurate cancer detection.
How similar studies have performed: While robotic bronchoscopy has been validated internationally, this specific application using remote technology and 5G is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.