Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pulmonary Coin Lesion	Procedure: Lung biopsy using Always On EM Tip Tracked Device	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy

Further study details as provided by Veran Medical Technologies:

Primary Outcome Measures:

Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm. [ Time Frame: Within 1 week ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	30
Study Start Date:	June 2011
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients recommended for a lung biopsy. 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. Other Name: Always On Electromagnetic Tip Tracked Diagnostic Yield

Arms

Assigned Interventions

Experimental: Patients recommended for a lung biopsy.

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.

Other Name: Always On Electromagnetic Tip Tracked Diagnostic Yield

Detailed 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389154

Contacts

Contact: Momen Wahidi, MD, MBA	919-668-0340
Contact: Matthew Beyea, RN	919-668-3040	matthew.beyea@duke.edu

Locations

United States, Massachusetts
St. Elizabeth's Medical Center	Not yet recruiting
Brighton, Massachusetts, United States, 02135
Contact: Armin Ernst, MD 617-789-2936
Contact: Arthur Brown 617-789-2936
Principal Investigator: Armin Ernst, MD
United States, Missouri
Barnes Jewish Hospital	Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Alexander Chen, MD 314-454-8764
Principal Investigator: Alexander Chen, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Momen Wahidi, MD, MBA 919-668-0304
Contact: Scott Shofer, MD, PhD 919-668-2402
Principal Investigator: Momen Wahidi, MD. MBA
Sub-Investigator: Scott Shofer, MD, PhD

Sponsors and Collaborators

Veran Medical Technologies

Institute for Quality Resource Management

Investigators

Principal Investigator:

Momen Wahidi, MD, MBA

Duke University

More Information

Additional Information:

Reduced Lung-Cancer Mortality with Low-Dose CT Screening This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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

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. Epub 2009 Dec 4. Review.

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.

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.

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.

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.

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.

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.

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. Epub 2008 Oct 5.

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.

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.

Responsible Party:	Mark Hunter Senior Vice President, Strategic Operations, Veran Medical Technologies
ClinicalTrials.gov Identifier:	NCT01389154 History of Changes
Other Study ID Numbers:	VMT-SPiN_01
Study First Received:	July 1, 2011
Last Updated:	July 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Veran Medical Technologies:

diagnostic yield
Electromagnetic Tip Tracked
peripheral lung lesion

Additional relevant MeSH terms:

Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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