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| Name | Class |
|---|---|
| Erbe USA Incorporated | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard forceps biopsy then research cryoprobe biopsy | Experimental | Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using forceps first followed by cryoprobe. |
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| Research cryoprobe biopsy then standard forceps biopsy | Experimental | Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using the cryoprobe first followed by forceps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoprobe biopsy | Device | A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Successfully Obtain Sample | Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Biopsy Procedure | Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens. | Biopsy procedure, approximately 3 hours |
| Freezing Time for Cryoprobe Biopsies |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Kern, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Forceps Biopsy First, Then Research Cryoprobe Biopsy | Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy first, then crossover to receive the research cryoprobe biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue |
| FG001 | Research Cryoprobe Biopsy First, Then Standard Forceps Biopsy | Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Research cryoprobe biopsy first, then crossover to receive the standard forceps biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Forceps Biopsy First, Then Research Cryoprobe Biopsy | Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy first, then crossover to receive the research cryoprobe biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Successfully Obtain Sample | Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis | Posted | Number | tissue samples | Baseline |
|
Adverse events were collected for each subject from baseline until completion of the standard of care post procedure follow-up for approximately 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Forceps Biopsy | Subjects who received standard forceps biopsy either first or second during their biopsy of lung lesions. Standard forceps biopsy: Biopsy forceps used to collect tissue |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan M. Kern, M.D. | Mayo Clinic | 507-266-3958 | Kern.Ryan@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2021 | Jun 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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| Forceps biopsy | Procedure | Biopsy forceps used to collect tissue |
|
Total freezing time for cryoprobe biopsies, measured in seconds
| Biopsy procedure, approximately 60 seconds |
| Number of Successful Biopsy Attempts | 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. | Biopsy procedure, approximately 3 hours |
| Histological Accessibility Grade | Pathologic description ranging from insufficient to diagnostic material | Pathology review, approximately 1 day |
| Histological Diagnostic Yield | 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. | Pathology review, approximately 1 day |
| Total Histological Area | The total histological area of the biopsy samples. Measured in (mm^2) | Pathology review, approximately 1 day |
| Crush Artifacts | The total percent area of crush artifacts identified in the biopsy samples (percent total area) | Pathology review, approximately 1 day |
| Other Pathologic Artifacts | The total percent area of other pathologic artifacts identified in the tissue biopsy samples that obscure pathological assessment (percent total area) | Pathology review, approximately 1 day |
| Different Tissue Types in the Tissue Specimen | 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) | Pathology review, approximately 1 day |
| NOT COMPLETED |
|
| BG001 | Research Cryoprobe Biopsy First, Then Standard Forceps Biopsy | Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Research cryoprobe biopsy first, then crossover to receive the standard forceps biopsy during the procedure. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue Standard forceps biopsy: Biopsy forceps used to collect tissue |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Duration of Biopsy Procedure | Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens. | Posted | Median | Inter-Quartile Range | minutes | Biopsy procedure, approximately 3 hours |
|
|
|
| Secondary | Freezing Time for Cryoprobe Biopsies | Total freezing time for cryoprobe biopsies, measured in seconds | This outcome measure was only collected and analyzed for the Research cryoprobe biopsy arm | Posted | Mean | Standard Deviation | seconds | Biopsy procedure, approximately 60 seconds |
|
|
|
| Secondary | Number of Successful Biopsy Attempts | 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. | Posted | Number | successful attempts | Biopsy procedure, approximately 3 hours |
|
|
|
| Secondary | Histological Accessibility Grade | Pathologic description ranging from insufficient to diagnostic material | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
|
|
| Secondary | Histological Diagnostic Yield | 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. | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
|
|
| Secondary | Total Histological Area | The total histological area of the biopsy samples. Measured in (mm^2) | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
|
|
| Secondary | Crush Artifacts | The total percent area of crush artifacts identified in the biopsy samples (percent total area) | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
|
|
| Secondary | Other Pathologic Artifacts | The total percent area of other pathologic artifacts identified in the tissue biopsy samples that obscure pathological assessment (percent total area) | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
|
|
| Secondary | Different Tissue Types in the Tissue Specimen | 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) | Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure | Posted | Pathology review, approximately 1 day |
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| 0 |
| 30 |
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| 30 |
| 3 |
| 30 |
| EG001 | Research Cryoprobe Biopsy | Subjects who received the research cryoprobe biopsy first or second during their biopsy of lung lesions. Cryoprobe biopsy: A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue | 0 | 30 | 0 | 30 | 2 | 30 |
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