Ensayos clínicos

Inclusion Criteria:

• Over 21 years of age.
• Capable and willing to give informed consent.
• Acceptable candidate for an elective, non-emergent bronchoscopic procedure.
• Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy.

Exclusion Criteria:

• Medical contraindication to bronchoscopy as assessed by the investigator.
• Presence of uncorrectable bleeding disorders.
• Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker.
• Patients with the target lesion having endobronchial involvement seen on chest CT.
• Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure.
• Participation in any other clinical trial within 30 days of enrollment that would interfere with this study.
• Uncontrolled or irreversible coagulopathy.
• Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure.
• CT scan done greater than 28 days before the bronchoscopy procedure.
• Any presenting condition discovered intra-procedurally that, in the opinion of the investigator, would make participating in this study not in the patient’s best interest. Reasons include, but are not limited to:
  • presence of unexpected endobronchial lesion (identified by conventional bronchoscopy);
  • adequate tissue acquisition obtained via EBUS-TBNA during the procedure, patient’s unstable clinical status during general anesthesia.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.