Steward Health Care System

Return to Results

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

new search

Trial Conditions
  • Pulmonary Coin Lesion
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
50 and older

Gender:
Both

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

Gender: Both
Steward Physician(s)
  • Momen Wahidi, MD, MBA
Trial Interventions
Procedure
  • Lung biopsy using Always On EM Tip Tracked Device
Physician Researcher

Investigator Name:

  • Momen Wahidi, MD, MBA

Other Information

Sponsor: Veran Medical Technologies
Phase: Phase 4
Trial ID: NCT01389154
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions