pulmonary nodules
Conditions
Interventions
Trial group:All patients will be included in trial group, and will undergo transthoracic puncture biopsy of pulmonary nodules assisted by the Navigation and Positioning System for puncture procedures
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: To be considered eligible and enrolled in the study, subjects must meet all of the following criteria: 1) Ages from 18 to 80 years old, inclusive. 2) Patients with pulmonary nodules suspected of being malignant, and with sizes greater than 8mm up to and including 30mm, are candidates for a transthoracic puncture biopsy. 3) The subjects or their guardians must be able to understand the purpose of the trial, voluntarily sign the informed consent, and be willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be deemed ineligible for the study: 1) Uncorrectable coagulation dysfunction; 2) Severe pulmonary hypertension; 3) Anatomical or functional isolation of the lung; 4) Obvious infectious lesions along the puncture path; 5) Severe pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 6) Patients with mechanical ventilation (ventilator); 7) Pregnant women or those planning to become pregnant during study period; 8) Situations deemed unsuitable for inclusion in the study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety during completion of protocol specified procedure assisted by trial device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of target puncture;One-time puncture success rate;Number of intraoperative needle adjustments;Number of CT scans;Puncture procedure time (min);The total radiation dose received by the patient (mGy*cm);Trial device performance evaluation; | — |
Countries
China
Contacts
Public ContactJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed