Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

University Health Network, Toronto

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: Navigational Bronchoscopy; Procedure: Standard Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01947530

12-5056-B

Details and patient eligibility

About

The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.

Exclusion criteria

• Pulmonary nodules less than 1.0 cm
• patients must be able to tolerate general anesthesia
• patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal
• patients unable to tolerate bronchoscopy
• pregnant patients or patients who believe they are pregnant
• patients with implantable devices susceptible to Radio Frequency (RF) fields
• severely obese patients

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Navigational Bronch/Standard Bronch

Active Comparator group

Description:

Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.

Treatment:

Procedure: Standard Bronchoscopy

Procedure: Navigational Bronchoscopy

Standard Bronch/Navigational Bronch

Active Comparator group

Description:

Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.

Treatment:

Procedure: Standard Bronchoscopy

Procedure: Navigational Bronchoscopy