Clinical trial NCT04486560: Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Official title: Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Keywords: lung
cryoprobe
bronchoscopic
biopsy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Erbe USA Incorporated
First posted: 2020-07-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: Within 30 days of procedure
Secondary outcomes:
measure: Number of Participants With Minor Adverse Events
timeFrame: Within 30 days of procedure
measure: Mean Histologic Accessibility Grade
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)
measure: Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis
timeFrame: During procedure, up to 1 hour
measure: Total Histologic Area (Square Millimeters)
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)
measure: Alveolated Area (Square Millimeters)
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)
measure: Open Alveoli Percent
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)
measure: Percent Crush Artifact
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)
measure: Artifact Free Lung Parenchyma Percent
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)
measure: Activation Time (Seconds)
timeFrame: At the time of procedure, up to 1 hour
measure: Procedure Time
timeFrame: At the time of procedure, up to 1 hour
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Johns Hopkins University
name: Lonny Yarmus
role: PRINCIPAL_INVESTIGATOR
References: