About this trial
This is a multicenter, single-arm, prospective, observational study designed to evaluate bronchoscopist radiation exposure during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Operator performing image-guided RAB on adult patients (age ≥18 years old)
A single participating operator per study site
Image-guided RAB procedure is planned for standard of care diagnostic sampling of a single parenchymal lung lesion at participating sites
Disqualifiers
Operator refusal to participate
Patients age <18 years old
Pregnant women
Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample >1 pulmonary parenchymal lesion
Trial population
Operator performing standard of care image-guided robotic-assisted bronchoscopy for the sampling of a single pulmonary parenchymal lesion
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
total operator radiation exposure dose
as captured by a radiation dosimetry badge over 50 consecutive procedures. All study procedures in which image-guided RAB was performed for the sampling of a single parenchymal lung lesion will be evaluable for the primary endpoint.
Sponsors and contacts
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