A Phase 4 interventional study of Lung biopsy using Always On EM Tip Tracked Device in Pulmonary Coin Lesion, sponsored by Veran Medical Technologies. Withdrawn. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.
Sponsored by Veran Medical Technologies (part of Olympus Corporation) · Phase 4, Interventional, and Diagnostic
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional bronchoscopy.
Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical Technologies system are Food and Durg Administration 510K approved for use in diagnostic pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter lung lesions or solitary pulmonary nodules(SPN).
Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to participate in the study and proceed with informed consent. An interim analysis of the data will be conducted to determine the need to include an additional 10 patients to achieve statistically significant results at the ninety five percent confidence interval.
88 studies on the registry are indexed under Solitary Pulmonary Nodule; 19 are open to participants now.
Browse Solitary Pulmonary Nodule studies →Veran Medical Technologies is the lead sponsor of 3 studies on the registry; none are open to participants now.
First submitted before Veran Medical Technologies became part of Olympus Corporation.
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Exclusion Criteria:
Patients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study.
Procedure: Lung biopsy using Always On EM Tip Tracked Device
Patients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment.
Also known as: Always On Electromagnetic Tip Tracked Diagnostic Yield
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures.
Time frame: Within 1 week
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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