Chest Computed Tomography (CT) or Positron Emission Tomography- Computed Tomography, PET-CT) that require location-based biopsy
Conditions
Interventions
Treatment group:Bronchoscope holding position navigation system and bronchoscope and accessories
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and <=75 years old, male or female; 2. Patients with peripheral lung lesions found by chest CT or PET-CT and requiring biopsy; 3. Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Refer to the Guidelines for the Application of Diagnostic Bendable Bronchoscopy in Adults (2019 Edition), there are contraindications for bronchoscopy. Such as acute myocardial infarction (within 4 weeks), massive active hemoptysis, platelet count < 60×10^9/L, malignant arrhythmia, unstable angina pectoris, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissections, aortic aneurysms, severe mental illness and extreme systemic failure, etc. 2. Bleeding tendency or coagulation dysfunction that cannot be corrected; 3. Antiplatelet or anticoagulant drugs are being used and cannot be properly managed before surgery (e.g. clopidogrel stopped 7 days before surgery, ticagrelor stopped 5 days before surgery, warfarin stopped 5 days before surgery, low molecular weight heparin stopped 24 hours before surgery, etc.); 4. Lactating or pregnant women; Patients with reproductive potential who have not taken reasonable contraceptive measures; 5. Visible lesions were found in the atmospheric duct during bronchoscopy; 6. Patients who have undergone pulmonary lobectomy; 7. Patients with electrical or magnetically activated implants or metal implants (non-titanium) in their bodies; 8. Allergic to narcotics; Or have a history of multiple severe allergies or hereditary allergies; 9. Participants who have participated in or are participating in drug clinical trials or other medical device clinical trials within 1 month before screening; 10. The investigator believes that the patient has any other conditions that are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Navigation success rate (case level);Navigation success rate (lesion level);Sampling success rate;Navigation time;operating time;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactLiang'an Chen
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed