Respiration Gated Laser Guided CT Lung Nodule Biopsy
Lung Cancer
Conditions: Keywords
CT, lung nodule biopsy, Respiration Gated, Lung Cancer
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Bellows-based breath hold device
Type: Device
Overall Status
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

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.
Gentofte University Hospital, Department of Radiology
Hellerup, Copenhagen, Denmark
Status: Recruiting
Contact: Haseem Ashraf, MD, PhD -
Start Date
March 2010
Completion Date
July 2012
University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Record processing date processed this data on July 28, 2015 page