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

NCT01389154 | Withdrawn Phase 4 DMC

• 1 other identifier: VMT-SPiN_01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Coin Lesion

Keywords

diagnostic yield; Electromagnetic Tip Tracked; peripheral lung lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients recommended for a lung biopsy.

EXPERIMENTAL

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

Interventions

Lung biopsy using Always On EM Tip Tracked Device PROCEDURE

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

Patients recommended for a lung biopsy.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veran Medical Technologies: lead
• Institute for Quality Resource Management: collaborator

Related Publications (14)

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• Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.

  PMID: 10492275 BACKGROUND

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  PMID: 12527568 BACKGROUND

• Alberg AJ, Samet JM. Epidemiology of lung cancer. Chest. 2003 Jan;123(1 Suppl):21S-49S. doi: 10.1378/chest.123.1_suppl.21s.

  PMID: 12527563 BACKGROUND

• 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.

  PMID: 19965952 BACKGROUND

• 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. doi: 10.1378/chest.129.1.147.

  PMID: 16424425 BACKGROUND

• 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. doi: 10.1159/000077424.

  PMID: 15133346 BACKGROUND

• 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. doi: 10.1371/journal.pone.0000346.

  PMID: 17406670 BACKGROUND

• 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. doi: 10.1183/09031936.00165306. Epub 2007 Mar 14.

  PMID: 17360724 BACKGROUND

• 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. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22.

  PMID: 17379850 BACKGROUND

• 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. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.

  PMID: 16873767 BACKGROUND

• 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.

  PMID: 18836886 BACKGROUND

• 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. doi: 10.1378/chest.129.4.988.

  PMID: 16608948 BACKGROUND

• 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. doi: 10.1378/chest.128.1.382.

  PMID: 16002960 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Momen Wahidi, MD, MBA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 7, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 18, 2014

Record last verified: 2014-07