Trial Outcomes & Findings for Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (NCT NCT04486560)
NCT ID: NCT04486560
Last Updated: 2022-02-25
Results Overview
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.
COMPLETED
NA
51 participants
Within 30 days of procedure
2022-02-25
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Baseline characteristics by cohort
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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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|---|---|
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Age, Continuous
|
60 years
STANDARD_DEVIATION 14 • n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
26 kg/m^2
STANDARD_DEVIATION 7 • n=93 Participants
|
|
Smoking Status
Never
|
28 Participants
n=93 Participants
|
|
Smoking Status
Current
|
2 Participants
n=93 Participants
|
|
Smoking Status
Former
|
20 Participants
n=93 Participants
|
|
Indication for Biopsy
Pulmonary Parenchymal Lesion
|
3 Participants
n=93 Participants
|
|
Indication for Biopsy
Diffuse Lung Disease
|
22 Participants
n=93 Participants
|
|
Indication for Biopsy
Lung Transplant
|
25 Participants
n=93 Participants
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Type of Airway
Laryngeal Mask Airway
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19 Participants
n=93 Participants
|
|
Type of Airway
Endotracheal Tube
|
21 Participants
n=93 Participants
|
|
Type of Airway
Rigid Bronchoscopy
|
10 Participants
n=93 Participants
|
|
Bronchial Blocker Used
|
8 Participants
n=93 Participants
|
|
Location of Biopsy
Right Upper Lobe
|
2 Participants
n=93 Participants
|
|
Location of Biopsy
Right Middle Lobe
|
2 Participants
n=93 Participants
|
|
Location of Biopsy
Right Lower Lobe
|
31 Participants
n=93 Participants
|
|
Location of Biopsy
Left Upper Lobe
|
3 Participants
n=93 Participants
|
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Location of Biopsy
Left Lower Lobe
|
12 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of procedureThe 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.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
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SECONDARY outcome
Timeframe: Within 30 days of procedureThe 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).
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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
|
|---|---|
|
Number of Participants With Minor Adverse Events
Grade 1 Pneumothorax
|
2 Participants
|
|
Number of Participants With Minor Adverse Events
Grade 1-2 Bleeding
|
25 Participants
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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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Mean Histologic Accessibility Grade
|
4.9 score on a scale
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: During procedure, up to 1 hourPopulation: The analysis was broken down by type of cryobiopsy indication.
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.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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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Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis
Lung Transplant
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23 Participants
|
|
Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis
Diffuse Lung Disease
|
16 Participants
|
|
Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis
Pulmonary Parenchymal Lesion
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)Amount of total histologic tissue in square millimeters observed under microscope.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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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Total Histologic Area (Square Millimeters)
|
54.4 square millimeters
Interval 21.1 to 87.7
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SECONDARY outcome
Timeframe: 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)Total amount of area in square millimeters containing alveoli.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=231 Number of Pieces
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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Alveolated Area (Square Millimeters)
Per Patient
|
11.39 square millimeters
Interval 0.0 to 51.6
|
|
Alveolated Area (Square Millimeters)
Per Piece
|
2.47 square millimeters
Interval 0.0 to 18.47
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SECONDARY outcome
Timeframe: 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)Percentage of all alveoli that are open.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=182 Number of Samples
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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Open Alveoli Percent
|
66.48 percent
Interval 0.0 to 100.0
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SECONDARY outcome
Timeframe: 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 of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=190 Number of samples
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
|
|---|---|
|
Percent Crush Artifact
|
0.5 percent
Interval 0.0 to 90.0
|
SECONDARY outcome
Timeframe: 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 of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=181 Number of Samples
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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Artifact Free Lung Parenchyma Percent
|
90.86 percent
Interval 0.0 to 100.0
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SECONDARY outcome
Timeframe: At the time of procedure, up to 1 hourTime of activation of cryoprobe.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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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Activation Time (Seconds)
|
4.2 seconds
Interval 3.2 to 5.2
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SECONDARY outcome
Timeframe: At the time of procedure, up to 1 hourTime for entire procedure measured in minutes.
Outcome measures
| Measure |
Single Arm: Cryoprobe
n=50 Participants
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
|
|---|---|
|
Procedure Time
|
22 minutes
Interval 10.0 to 38.0
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Adverse Events
Single Arm: Cryoprobe
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm: Cryoprobe
n=50 participants at risk
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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Respiratory, thoracic and mediastinal disorders
SECONDARY SAFETY ENDPOINT Adverse Event
|
44.0%
22/50 • Number of events 22 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place