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

This study has been withdrawn prior to enrollment.
(Product Enhancements completed)
Sponsor:
Collaborator:
Institute for Quality Resource Management
Information provided by (Responsible Party):
Veran Medical Technologies
ClinicalTrials.gov Identifier:
NCT01389154
First received: July 1, 2011
Last updated: July 16, 2014
Last verified: July 2014
  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.


Enrollment: 0
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Veran Medical Technologies
Institute for Quality Resource Management
Investigators
Principal Investigator: Momen Wahidi, MD, MBA Duke University
  More Information

Additional Information:
Publications:

Responsible Party: 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 16, 2014
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 July 20, 2014