Respiration Clinical Trial
Official title:
Use of an Optical Breath-hold Control (OBC) System for Image-guided Interventional Radiology Procedures: A Feasibility Study
The objective or our study is to test the feasibility of a new optical-based breath-hold control (OBC) system for monitoring breath-hold levels and providing patient feedback during CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.
1. Specific Aim #1: To further test the feasibility of the new OBC system for guiding
accurate and reproducible breath-hold levels that correlate with internal target
position in human volunteers. Hypothesis: The OBC system is as good as or better than
the currently used IBC system with regard to accuracy and reproducibility of a
reference breath-hold level.
2. Specific Aim #2: To compare the use of 2 optical-based belts (wrapped around the chest
and abdomen) versus 1 optical-based belt (wrapped around the chest or abdomen,
depending on which region expands the most during respiration) with regard to accuracy
and reproducibility of a pre-determined reference breath-hold level in a subset of
patients (prone and/or obese). Hypothesis: The use of 2 optical-based belts allows
increased accuracy and reproducibility of a pre-determined reference breath-hold level
compared with the use of only one belt in this subset of patients.
3. Specific Aim #3: To test the clinical feasibility of the new OBC system in patients
undergoing CT-guided biopsy of the lung or upper abdomen where respiratory motion is a
problem. Hypothesis: The OBC system is as good as or better than the currently used IBC
system with regard to the accuracy and reproducibility of the reference breath-hold and
ease of use.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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