C34
Conditions
Interventions
Group 1: The aim of this study is to evaluate the diagnostic yield and safety aspects of the routine use of the robotic ION™ Endoluminal System for sampling peripheral pulmonary nodules and mediastina
Sponsors
Thoraxklinik Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical indication for bronchoscopy in cases of suspected lung cancer or metastases from other tumors • Peripheral pulmonary lesion = 3 cm • Indication for lymph node staging (lymph nodes =1 cm on computed tomography and/or multiple lesions on PET-CT, number of enlarged lymph nodes with indication for diagnosis not limited) • Patient is willing and able to understand and assess the information, benefits, and risks of the treatment
Exclusion criteria
Exclusion criteria: - Anticoagulation that cannot be paused or coagulation disorder that, in the opinion of the investigator, poses an increased peri-interventional risk • Increased risk of prolonged anesthesia time based on pre-existing conditions or clinical assessment by the investigator, which does not correspond to an adequate risk-benefit ratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and Safety of pulmonary nodules and lmyph node puncture - Feasibility: At the time of bronchoscopy (is it possible to puncture the nodules and lymph nodes?) - Safety: Recording of all complications up to 3 months after bronchoscopy (medical history) | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic yield, safety, navigational success, technical success, sample size, tool-in-lesion, characteristics and localization of pulmonary nodules and lymph nodes, procedure times, patient satisfaction, surgical outcome | — |
Countries
Germany
Contacts
Public ContactJudith Brock
Thoraxklinik Heidelberg
Outcome results
None listed