Recruiting NCT07318402
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Operator Radiation Exposure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- total operator radiation exposure dose [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Operator refusal to participate
- Image-guided RAB procedure performed on:
- Patients age <18 years old
- Pregnant women
- Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample >1 pulmonary parenchymal lesion
- Patients undergoing standard of care robotic assisted bronchoscopy for lesion localization (injection of dye/marker or fiducial marker deployment)
- Patients undergoing standard of care robotic assisted bronchoscopy for a therapeutic intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Orlando Health (Data Collection Only) — Orlando
- Emory University (Data Collection Only) — Atlanta
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
Identifiers
NCT: NCT07318402 · 25-350