Space-occupying lesions in the chest and abdomen
Conditions
Interventions
1:Interventional diagnosis and treatment operation navigation system and disposable coaxial navigation needle
2:Coaxial guided biopsy needle
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old (including 18 and 65 years old), regardless of gender; 2. Clinical and imaging diagnosis is a space-occupying lesion of the chest or abdomen, and a needle biopsy is required; 3. The diameter of the lesion <= 50mm; 4. Can cooperate with this study; 5. Volunteer to participate in this clinical trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who need more than 1 biopsy; 2. Uncorrectable coagulation dysfunction, or bleeding; 3. Severe cardiopulmonary insufficiency (such as severe pulmonary hypertension); 4. Severe hepatic and renal insufficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal, alkaline phosphatase (ALP) > 5 times the upper limit of normal, total bilirubin (TBil) > 3 times the upper limit of normal, serum creatinine (Scr) > 178 µmol/L), combined with other clinical manifestations, comprehensively determined by the investigator; 5. Obvious infectious lesions on the puncture path; 6. Pregnant or lactating women; 7. Using devices that are subject to electromagnetic interference (such as pacemakers) or implants that can interfere with electromagnetics; 8. Patients who have other counter-indications for CT-guided needle biopsy treatment or other reasons unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The positioning success rate with the number of puncture adjustments not greater than 2;Adverse events;Performance; | — |
Secondary
| Measure | Time frame |
|---|---|
| The positioning success rate, positioning accuracy, and the total number of CT scans when the number of puncture adjustments is not greater than one; | — |
Countries
China
Contacts
Public ContactXiaoyi Ding
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed