Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Overview

About this study

The primary objective of this trial is to determine safety of the robotic bronchoscopy procedures performed in routine clinical practice at multiple centers. Secondary objectives include overall safety assessment as well as description of diagnostic accuracy of the robotassisted bronchoscopy procedure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Karen Swanson, D.O.

Closed for enrollment

Contact information:

Sejal Patel CCRP

(480) 342-2942

Patel.Sejal@mayo.edu

More information

Publications

Publications are currently not available
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