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


Phase 4
50 Years
N/A
Open (Enrolling)
Both
Pulmonary Coin Lesion

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.

Outcome Description:

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.

Outcome Time Frame:

Within 1 week

Safety Issue:

No

Principal Investigator

Momen Wahidi, MD, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

VMT-SPiN_01

NCT ID:

NCT01389154

Start Date:

June 2011

Completion Date:

November 2011

Related Keywords:

  • Pulmonary Coin Lesion
  • diagnostic yield
  • Electromagnetic Tip Tracked
  • peripheral lung lesion
  • Solitary Pulmonary Nodule

Name

Location
St. Elizabeth's Medical Center Boston, Massachusetts  02135-2997
Duke University Medical Center Durham, North Carolina  27710
Barnes Jewish Hospital St. Louis, Missouri  63110