Skip to content

A Prospective, Single-Center, Feasibility Clinical Study to Evaluate the Effectiveness and Safety of an Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules

A Prospective, Single-Center, Feasibility Clinical Study to Evaluate the Effectiveness and Safety of an Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules - A Prospective, Single-Center, Feasibility Clinical Study on the Application of an Electromagnetic Navigation Bronchoscopy System in Diagnosing Peripheral Pulmonary Nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115200
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-26
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PeripheralPulmonary Nodule,PPN

Interventions

Experimental group:Electronic Bronchoscopic Navigation Control System

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Able to tolerate and suitable for bronchoscope surgery; 2. Age > =18 years old and < 80 years old; 3. Patients who have a peripheral pulmonary nodule (PPN) detected in their chest CT scan and require biopsy; 4. The maximum diameter of the entire nodule is greater than 8mm but not greater than 30mm; 5. Able to understand and adhere to research requirements, and capable of providing and signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general condition and weak constitution, who are assessed by the researcher as unable to tolerate bronchoscope catheter examination; 2. The target nodule has been diagnosed as a malignant tumor or metastatic tumor; During the bronchoscopy procedure, the target nodule was confirmed as a central-type lesion; 4. Referring to the "Guidelines for the Application of Diagnostic Flexible Bronchoscopy in Adults (2019 Edition)", there are contraindications to bronchoscopy, such as acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count <60x10^9, malignant arrhythmia, unstable angina pectoris, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension with intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness, and extreme systemic failure; 5. Contraindications to intubation or general anesthesia; 6. Known to be allergic, sensitive, or have had an allergic reaction to materials or anesthetics that come into direct contact with the human body; 7. Patients with implanted cardiac pacemakers; 8. Patients with uncorrectable bleeding tendency or impaired coagulation mechanism; 9. Pregnancy; 10. Any other conditions identified by the principal investigator or bronchoscopy physician during the pre-bronchoscopy assessment that may increase the risk of bronchoscopy surgery; 11. Other situations that researchers consider unsuitable for participation in the study; 12.Individuals who have participated or are currently participating in a drug clinical trial within the past 12.3 months (participation in non-interventional trials is also acceptable), or who have participated or are currently participating in another medical device clinical trial within the past month (participation in non-interventional trials is also acceptable).

Design outcomes

Primary

MeasureTime frame
Navigation success rate;

Countries

China

Contacts

Public ContactJiayuan Sun

Shanghai Chest Hospital

jysun1976@163.com+86 180 1732 1598

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026