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| Name | Class |
|---|---|
| Erbe USA Incorporated | OTHER |
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The purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bronchoscopic approach.
A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe.
This study does not involve randomization or assigning different patients to different procedures to compare. Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only difference from the standard of care approach is that the physician performing the transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.
Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: Cryoprobe | Experimental | Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 | Device | ERBE 1.1mm flexible single-use cryoprobe with oversheath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death. | Within 30 days of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Minor Adverse Events | The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1). | Within 30 days of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lonny Yarmus | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21218 | United States | ||
| Vanderbilt University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Cryoprobe | Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Cryoprobe | Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath |
| 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 | Number of Participants With Serious Adverse Events | The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death. | Posted | Count of Participants | Participants | Within 30 days of procedure |
|
Day of procedure through 30 days post-procedure
Primary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade ≥ 3, pneumothorax grade ≥ 2, post-procedure respiratory failure, and/or death related to the device.
Secondary Safety Endpoint Serious Adverse Event: Occurrence of bleeding grade < 3 and/or pneumothorax grade < 2 related to the device.
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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 | Single Arm: Cryoprobe | Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651: ERBE 1.1mm flexible single-use cryoprobe with oversheath |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SECONDARY SAFETY ENDPOINT Adverse Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurrence of bleeding grade < 3 and/or pneumothorax grade < 2 related to the device |
All procedures were performed at large academic centers so procedural volume and pathology may not be generalizable. Larger proportion of lung transplant patients enrolled means there is a lack of heterogeneity in disease entities. Study aimed to address safety so the design and sample size is too small to accurately estimate diagnostic yield. Sheath was required for all cases, precluding use of robotic-assisted bronchoscopy (and underrepresentation of lung cancer).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lonny Yarmus | Johns Hopkins University | 410-502-5224 | lyarmus@jhmi.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 | Oct 1, 2020 | Dec 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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This is a multi-center, non-randomized, single-arm, prospective trial. Therefore, all participants will have their transbronchial biopsy with the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.
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| Mean Histologic Accessibility Grade | Grade 0: Does not contain alveolar structures and can therefore not be assessed Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis | Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic. | During procedure, up to 1 hour |
| Total Histologic Area (Square Millimeters) | Amount of total histologic tissue in square millimeters observed under microscope. | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Alveolated Area (Square Millimeters) | Total amount of area in square millimeters containing alveoli. | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Open Alveoli Percent | Percentage of all alveoli that are open. | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Percent Crush Artifact | Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology. | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Artifact Free Lung Parenchyma Percent | Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact. | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
| Activation Time (Seconds) | Time of activation of cryoprobe. | At the time of procedure, up to 1 hour |
| Procedure Time | Time for entire procedure measured in minutes. | At the time of procedure, up to 1 hour |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Smoking Status | Count of Participants | Participants |
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| Indication for Biopsy | Count of Participants | Participants |
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| Type of Airway | Count of Participants | Participants |
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| Bronchial Blocker Used | Participants in whom bronchial blocker was used. | Count of Participants | Participants |
|
| Location of Biopsy | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Minor Adverse Events | The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1). | Posted | Count of Participants | Participants | Within 30 days of procedure |
|
|
|
| Secondary | Mean Histologic Accessibility Grade | Grade 0: Does not contain alveolar structures and can therefore not be assessed Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features | Posted | Mean | Standard Deviation | score on a scale | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
|
|
|
| Secondary | Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis | Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic. | The analysis was broken down by type of cryobiopsy indication. | Posted | Count of Participants | Participants | During procedure, up to 1 hour |
|
|
|
| Secondary | Total Histologic Area (Square Millimeters) | Amount of total histologic tissue in square millimeters observed under microscope. | Posted | Mean | Full Range | square millimeters | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) |
|
|
|
| Secondary | Alveolated Area (Square Millimeters) | Total amount of area in square millimeters containing alveoli. | Posted | Mean | Full Range | square millimeters | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | Number of Pieces | Number of Pieces |
|
|
|
| Secondary | Open Alveoli Percent | Percentage of all alveoli that are open. | Posted | Mean | Full Range | percent | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | Number of Samples | Number of Samples |
|
|
|
| Secondary | Percent Crush Artifact | Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology. | Posted | Mean | Full Range | percent | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | Number of samples | Number of samples |
|
|
|
| Secondary | Artifact Free Lung Parenchyma Percent | Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact. | Posted | Mean | Full Range | percent | Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) | Number of Samples | Number of Samples |
|
|
|
| Secondary | Activation Time (Seconds) | Time of activation of cryoprobe. | Posted | Mean | Full Range | seconds | At the time of procedure, up to 1 hour |
|
|
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| Secondary | Procedure Time | Time for entire procedure measured in minutes. | Posted | Mean | Full Range | minutes | At the time of procedure, up to 1 hour |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 22 |
| 50 |
|
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| Pulmonary Parenchymal Lesion |
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