Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices

Pulmonary Coin Lesion Clinical Trial

— ALOSPNDY  

Official title:

A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01389154
• Other study ID #: VMT-SPiN_01
• Status: Withdrawn
• Phase: Phase 4
• First received: July 1, 2011
• Last updated: July 16, 2014
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: July 2014
• Source: Veran Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subject provides informed consent

• Subject is older than 50 years of age with 50% of patients at least 65 years of age

• Patient has a minimum of 20 pack years

• Subject scheduled to undergo conventional bronchoscopy as part of their standard medical care

• Subject has radiographically confirmed sub-segmental peripheral < 3.0 cm lung lesions

• A negative pregnancy test in women of child-bearing potential

• Subject is willing and able to return for all required follow-up

• Subject is mentally capable of following study directions

Exclusion Criteria:

• Subject has pacemaker, implantable cardioverter, and/or defibrillator

• Subject has any disease or condition that interferes with safe completion of initial or follow-up assessments

• Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy prior to their enrollment in this study

• Concurrent participation in another study involving investigational drugs or investigational medical devices

• Inability to read and understand the necessary study documents

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Coin Lesion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Veran Medical Technologies	Institute for Quality Resource Management

References & Publications (14)

Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. Review. — View Citation

Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. Epub 2007 Mar 22. — View Citation

Edell E, Krier-Morrow D. Navigational bronchoscopy: overview of technology and practical considerations--new Current Procedural Terminology codes effective 2010. Chest. 2010 Feb;137(2):450-4. doi: 10.1378/chest.09-2003. Epub 2009 Dec 4. Review. — View Citation

Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. Epub 2006 Jul 27. — View Citation

Hautmann H, Schneider A, Pinkau T, Peltz F, Feussner H. Electromagnetic catheter navigation during bronchoscopy: validation of a novel method by conventional fluoroscopy. Chest. 2005 Jul;128(1):382-7. — View Citation

Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. — View Citation

Lamprecht B, Porsch P, Pirich C, Studnicka M. Electromagnetic navigation bronchoscopy in combination with PET-CT and rapid on-site cytopathologic examination for diagnosis of peripheral lung lesions. Lung. 2009 Jan-Feb;187(1):55-9. doi: 10.1007/s00408-008-9120-8. Epub 2008 Oct 5. — View Citation

Landi S, Cenni MC, Maffei L, Berardi N. Environmental enrichment effects on development of retinal ganglion cell dendritic stratification require retinal BDNF. PLoS One. 2007 Apr 4;2(4):e346. — View Citation

Makris D, Scherpereel A, Leroy S, Bouchindhomme B, Faivre JB, Remy J, Ramon P, Marquette CH. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. Eur Respir J. 2007 Jun;29(6):1187-92. Epub 2007 Mar 14. — View Citation

Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Solèr M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. — View Citation

Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. Review. — View Citation

Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. — View Citation

Shirakawa T, Imamura F, Hamamoto J, Honda I, Fukushima K, Sugimoto M, Shirkakusa T. Usefulness of endobronchial ultrasonography for transbronchial lung biopsies of peripheral lung lesions. Respiration. 2004 May-Jun;71(3):260-8. — View Citation

Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD; American College of Chest Physicians. The solitary pulmonary nodule. Chest. 2003 Jan;123(1 Suppl):89S-96S. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 week	No

External Links

•   Reduced Lung-Cancer Mortality with Low-Dose CT Screening