Optical Breath-hold Control System for Image-guided Procedures (OBC)
|ClinicalTrials.gov Identifier: NCT01062789|
Recruitment Status : Withdrawn (Closed due to funding and never enrolled a subject)
First Posted : February 4, 2010
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Respiration||Device: Optical breath-hold control system (OBC)||Early Phase 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of an Optical Breath-hold Control (OBC) System for Image-guided Interventional Radiology Procedures: A Feasibility Study|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Use of an optical breath-hold control device
This is a feasibility study that will use this new device in place of a different bellows-based breath-hold control device for a series patients undergoing CT-guided lung biopsy. The new belt will be used in all patients in our study.
Device: Optical breath-hold control system (OBC)
The OBC system was designed to replace the IBC rubber bellows respiration sensor system that we are currently using for CT-guided lung biopsies. Unlike the IBC, the OBC is 1) unaffected by temperature changes, 2) has a linear sensitivity (for easier use and better accuracy), 3) has no pneumatic purge time when setting reference breath-hold level (reducing the chance of an inappropriate reference), 4) has no pneumatic cable that can occasionally interfere and get pinched during procedures, 5) is ambulatory (so patients can more easily familiarize themselves with the device before the procedure), 6) is capable of indicating proper fitting tension, 7) allows for easier binding (wireless pairing with other system components), and 8) is significantly less expensive (and possibly disposable).
- Ability to monitor patient respiration (return of target to same anatomical position) [ Time Frame: Measured daily for each individual procedure ]
- Needle Placement Time [ Time Frame: Measured daily for each individual procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062789
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Principal Investigator:||Stephanie K Carlson, MD||Mayo Clinic|