Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (FROSTBITE)

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female, ≥ 18-years-old
• Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist

Exclusion Criteria:

• Pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment
• Individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic > 200 mmHg or diastolic > 110 mmHg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months)
• Presence of bleeding disorder
• 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)
• International Normalized Ratio (INR) <1.5
• Robotic Bronchoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651; ERBE 1.1mm flexible single-use cryoprobe with oversheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Erbe USA Incorporated
• Investigators: Principal Investigator: Lonny Yarmus, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: lung; biopsy; bronchoscopic; cryoprobe
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IRB00235679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No