NCT04486560: FROSTBITE

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique

Completed NA Results posted Last updated 25 February 2022

What this trial tests

NA trial testing ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 in Lung Diseases in 51 participants. Completed in 31 January 2022.

Timeline

7 July 2020

Primary endpoint
29 November 2021

31 January 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	51
Start date	7 July 2020
Primary completion	29 November 2021
Estimated completion	31 January 2022
Sites	2 locations across United States

Drugs / interventions tested

• ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Conditions studied

• Lung Diseases — all drugs for Lung Diseases →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Lung Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious Adverse Events Primary · Within 30 days of procedure

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.

Group	Value	95% CI
Single Arm: Cryoprobe	0

Number of Participants With Minor Adverse Events Secondary · Within 30 days of procedure

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).

Grade 1 Pneumothorax

Group	Value	95% CI
Single Arm: Cryoprobe	2

Grade 1-2 Bleeding

Group	Value	95% CI
Single Arm: Cryoprobe	25

Mean Histologic Accessibility Grade Secondary · 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

Group	Value	95% CI
Single Arm: Cryoprobe	4.9	± 1.3

Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis Secondary · During procedure, up to 1 hour

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.

Lung Transplant

Group	Value	95% CI
Single Arm: Cryoprobe	23

Diffuse Lung Disease

Group	Value	95% CI
Single Arm: Cryoprobe	16

Pulmonary Parenchymal Lesion

Group	Value	95% CI
Single Arm: Cryoprobe	1

Total Histologic Area (Square Millimeters) Secondary · 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.

Group	Value	95% CI
Single Arm: Cryoprobe	54.4	21.1 – 87.7

Alveolated Area (Square Millimeters) Secondary · 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.

Per Patient

Group	Value	95% CI
Single Arm: Cryoprobe	11.39	0 – 51.6

Per Piece

Group	Value	95% CI
Single Arm: Cryoprobe	2.47	0 – 18.47

Open Alveoli Percent Secondary · 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.

Group	Value	95% CI
Single Arm: Cryoprobe	66.48	0 – 100

Percent Crush Artifact Secondary · 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.

Group	Value	95% CI
Single Arm: Cryoprobe	0.5	0 – 90

Artifact Free Lung Parenchyma Percent Secondary · 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.

Group	Value	95% CI
Single Arm: Cryoprobe	90.86	0 – 100

Activation Time (Seconds) Secondary · At the time of procedure, up to 1 hour

Time of activation of cryoprobe.

Group	Value	95% CI
Single Arm: Cryoprobe	4.2	3.2 – 5.2

Procedure Time Secondary · At the time of procedure, up to 1 hour

Time for entire procedure measured in minutes.

Group	Value	95% CI
Single Arm: Cryoprobe	22	10 – 38

Adverse events — posted to ClinicalTrials.gov

Time frame: Day of procedure through 30 days post-procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm: Cryoprobe

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Single Arm: Cryoprobe
SECONDARY SAFETY ENDPOINT Adverse Event	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT04486560 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.