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OpenTrials
Completed

NCT Number: NCT05399082

Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.

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Key information

Conditions

Bronchi--Diseases Bronchial Diseases Lesions Mass Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

  • Pulmonary nodules of 8-50mm in largest dimension.

Exclusion criteria

  • Patients with known bleeding diathesis; Platelet count < 50,000.
  • Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
  • Inability or unwillingness to give informed consent.
  • Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
  • Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
  • Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
  • International Normalized Ratio (INR) < 1.5.
  • Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Treatment and study plan

Cryoprobe biopsy

Device

A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue

Forceps biopsy

Procedure

Biopsy forceps used to collect tissue

Primary outcomes

  1. Ability to Successfully Obtain Sample

    Time frame: Baseline

    Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

Secondary outcomes

  1. Duration of Biopsy Procedure

    Time frame: Biopsy procedure, approximately 3 hours

    Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.

  2. Freezing Time for Cryoprobe Biopsies

    Time frame: Biopsy procedure, approximately 60 seconds

    Total freezing time for cryoprobe biopsies, measured in seconds

  3. Number of Successful Biopsy Attempts

    Time frame: Biopsy procedure, approximately 3 hours

    One attempt is defined as insertion of the biopsy probe into the robotic sheath, activation/employment of the biopsy mechanism at the target site and retrieval via the robotic sheath. A biopsy attempt is successful if a tissue sample that is considered by the bronchoscopist to be adequate for further pathological analysis can be retrieved.

  4. Histological Accessibility Grade

    Time frame: Pathology review, approximately 1 day

    Pathologic description ranging from insufficient to diagnostic material

  5. Histological Diagnostic Yield

    Time frame: Pathology review, approximately 1 day

    Defined as the ability of the pathologist to make a diagnostic statement based on the histological analysis of the obtained tissue samples. Graded 1-4 with 1 being insufficient tissue and 4 being diagnostic material.

  6. Total Histological Area

    Time frame: Pathology review, approximately 1 day

    The total histological area of the biopsy samples. Measured in (mm^2)

  7. Crush Artifacts

    Time frame: Pathology review, approximately 1 day

    The total percent area of crush artifacts identified in the biopsy samples (percent total area)

  8. Other Pathologic Artifacts

    Time frame: Pathology review, approximately 1 day

    The total percent area of other pathologic artifacts identified in the tissue biopsy samples that obscure pathological assessment (percent total area)

  9. Different Tissue Types in the Tissue Specimen

    Time frame: Pathology review, approximately 1 day

    The total percent area of different tissue types identified in the tissue biopsy samples. Defined as the total of alveoli, bronchus, mucus, blood, and target tissue (percent total area)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Erbe USA Incorporated

Registry information

Official study title

A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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