An interventional study of Bellows-based breath hold device in Lung Cancer, sponsored by University Hospital, Gentofte, Copenhagen. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2010-11-09.
Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Diagnostic
The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
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Patients with indeterminate lung nodules referred from the department of pulmonary medicine at Gentofte Hospital, Denmark for a CT guided biopsy are considered for inclusion in this study. The biopsy was preformed as part of regular clinical work up of the patient at the department of Radiology Gentofte Hospital, Denmark. Both men and women were included and no age restrictions were applied.
Exclusion Criteria:
Excluded from biopsy were those with poor pulmonary function test with a forced expired volume in the first second (FEV1) \< 0.5 L, INR>1.2, blood cloth level under 200* and ECG with sign of ischemic heart disease. The trial is planned to begin 1.March 2010 and run for 2 years ending at 29 February 2012. During this time approx. 400 participants planned for biopsy are accepted to be included in the trial.
CT guided biopsy is preformed with the use a bellows-based breath
Device: Bellows-based breath hold device
CT guided biopsy is preformed without the use a bellows-based breath
Device: Bellows-based breath hold device
Bellows-Based breath hold monitoring system: The bellows-based breath hold system (IBC, Mayo Clinic Medical Devices, USA) contains of 2 elements; one belt which is strapped around the thorax of the patient and a voltage controlled light unit with 8 lights. Belt stretch from respiratory motion is converted into voltage readings and displayed on the light unit giving biofeedback as different lights are activated depending on the dept of the respiration. Patients are instructed to keep respiration constant at a certain dept during the second the guide needle is inserted by controlling their breath with the help of the light unit. The patient is given a brief introduction to the system as to how the lights get turned on and off due to respiration motion before the biopsy is preformed.
Accuracy of respiration gated laser guided CT lung nodule biopsy
The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system.
Time frame: After 2 years
This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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