Clinical trial · Interventional
Respiration Gated Laser Guided CT Lung Nodule Biopsy
NCT01236937CI-TRIAL-00004097GENCTBIOPSYunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bellows-based breath hold device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bellows-based breath hold biopsy
- description
- CT guided biopsy is preformed with the use a bellows-based breath
- interventionNames
- Device: Bellows-based breath hold device
- type
- NO_INTERVENTION
- label
- No Bellows-based breath hold.
- description
- CT guided biopsy is preformed without the use a bellows-based breath
- interventionNames
- Device: Bellows-based breath hold device
Primary outcomes (1)
- measure
- Accuracy of respiration gated laser guided CT lung nodule biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.