Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass
Conditions
Brief summary
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.
Interventions
DEVICECryoprobe biopsy
A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
PROCEDUREForceps biopsy
Biopsy forceps used to collect tissue
Sponsors
Erbe USA Incorporated
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Successfully Obtain Sample | Baseline | Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freezing Time for Cryoprobe Biopsies | Biopsy procedure, approximately 60 seconds | Total freezing time for cryoprobe biopsies, measured in seconds |
| Number of Successful Biopsy Attempts | 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. |
| Histological Accessibility Grade | Pathology review, approximately 1 day | Pathologic description ranging from insufficient to diagnostic material |
| Histological Diagnostic Yield | 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. |
| Duration of Biopsy Procedure | Biopsy procedure, approximately 3 hours | Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens. |
| Crush Artifacts | Pathology review, approximately 1 day | The total percent area of crush artifacts identified in the biopsy samples (percent total area) |
| Other Pathologic Artifacts | 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) |
| Different Tissue Types in the Tissue Specimen | 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) |
| Total Histological Area | Pathology review, approximately 1 day | The total histological area of the biopsy samples. Measured in (mm\^2) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard Forceps Biopsy First, Then Research Cryoprobe Biopsy | Total | Research Cryoprobe Biopsy First, Then Standard Forceps Biopsy |
|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 9.23 | 70.3 years STANDARD_DEVIATION 8.4 | 70.2 years STANDARD_DEVIATION 7.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 29 Participants | 15 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 3 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Ability to Successfully Obtain Sample
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Forceps Biopsy | Ability to Successfully Obtain Sample | 123 tissue samples |
| Research Cryoprobe Biopsy | Ability to Successfully Obtain Sample | 130 tissue samples |
Secondary
Crush Artifacts
The total percent area of crush artifacts identified in the biopsy samples (percent total area)
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure
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)
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure
Secondary
Duration of Biopsy Procedure
Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.
Time frame: Biopsy procedure, approximately 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Forceps Biopsy | Duration of Biopsy Procedure | 41 minutes |
| Research Cryoprobe Biopsy | Duration of Biopsy Procedure | 41 minutes |
Secondary
Freezing Time for Cryoprobe Biopsies
Total freezing time for cryoprobe biopsies, measured in seconds
Time frame: Biopsy procedure, approximately 60 seconds
Population: This outcome measure was only collected and analyzed for the Research cryoprobe biopsy arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Research Cryoprobe Biopsy | Freezing Time for Cryoprobe Biopsies | 4.54 seconds | Standard Deviation 0.91 |
Secondary
Histological Accessibility Grade
Pathologic description ranging from insufficient to diagnostic material
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure
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.
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure
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.
Time frame: Biopsy procedure, approximately 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Forceps Biopsy | Number of Successful Biopsy Attempts | 123 successful attempts |
| Research Cryoprobe Biopsy | Number of Successful Biopsy Attempts | 130 successful attempts |
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)
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure
Secondary
Total Histological Area
The total histological area of the biopsy samples. Measured in (mm\^2)
Time frame: Pathology review, approximately 1 day
Population: Data was not collected nor analyzed due to inadequate tissue size, volume, and quality, no data were collected for this Outcome Measure