Cryoprobe Versus Forceps for Transbronchial Biopsy

Lung Diseases Clinical Trial

— FROSTBITE-2  

Official title:

A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05751278
• Other study ID #: IRB00344800
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of transbronchial biopsy done by a 1.1mm cryoprobe versus the standard 2.0mm forceps.

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.

For this study, patients will be randomized in a 1:1 fashion to transbronchial biopsy using a 1.1 mm cryoprobe versus 2.0 mm forceps, stratified by indication (evaluation of lung transplant allograft, diffuse parenchymal lung disease or pulmonary parenchymal lesion). Blinding of the proceduralist is not possible due to the nature of the procedure. Pathologists interpreting the biopsy samples will be blinded to the biopsy device used.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female, = 18-years-old

• Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care

Exclusion Criteria:

• Pregnant or nursing woman or woman of child-bearing potential who refuse to take a pregnancy test prior to enrollment

• Severe pulmonary hypertension (RVSP > 60 mmHg)

• Stroke within the last 6 months or myocardial infarction within the last 3 months

• Presence of bleeding disorder

• Platelet count < 50,000 per mL at time of enrollment

• Use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended time prior to invasive procedure (aspirin monotherapy is acceptable)

• Do Not Resuscitate (DNR) status

• Do Not Intubate (DNI) status

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
ERBE 1.1mm flexible single-use cryoprobe with oversheath
• Radial Jaw 4 Pulmonary Biopsy Forceps
Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Medicine	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Vanderbilt University Medical Center (VUMC)	Nashville	Tennessee
United States	NYU Langone Health	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Erbe USA Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis	Diagnostic Yield as Assessed by Number of Patients for Which the Procedure [Cryobiopsy or Forceps] Led to a Diagnosis.	During procedure, up to 1 hour
Secondary	Diagnostic yield for pulmonary parenchymal lesions	Diagnostic Yield as Assessed by Number of Patients with pulmonary parenchymal lesions for Which the Procedure [Cryobiopsy or Forceps] Led to a Diagnosis.	During procedure, up to 1 hour
Secondary	Diagnostic yield for diffuse parenchymal lung disease	Diagnostic Yield as Assessed by Number of Patients with diffuse parenchymal lung disease for Which the Procedure [Cryobiopsy or Forceps] Led to a Diagnosis.	During procedure, up to 1 hour
Secondary	Diagnostic yield for Lung Transplant	Diagnostic Yield as Assessed by Number of Patients with a Lung Transplant for Which the Procedure [Cryobiopsy or Forceps] Led to a Diagnosis.	During procedure, up to 1 hour
Secondary	Histological Accessibility grade of the biopsy specimen	7-point Likert scale: 0-6 with 0 being worse and 6 being best.	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Bleeding Complication Rate	Number of occurrences of bleeding (grade = 3 modified CTCAE).	Within 30 days of procedure
Secondary	Pneumothorax Complication Rate	Number of occurrences of pneumothorax requiring chest tube placement (grade = 2, CTCAE).	Within 30 days of procedure
Secondary	Post-Procedure Respiratory Failure Rate	Number of occurrences of post-procedure respiratory failure (defined as the need for non-invasive or mechanical ventilation requiring ICU admission).	Within 30 days of procedure
Secondary	Number of deaths	Number of occurrences of death.	Within 30 days of procedure
Secondary	Total Histologic Area	Total Histologic Area in Square Millimeters.	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Alveolated Area	Alveolated Area Square Millimeters	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Percent Crush Artifact	Percent total area for Crush Artifact.	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Artifact-free lung parenchyma	Percent Artifact-free lung parenchyma.	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Adequacy for Molecular Testing	Assessed as a yes or no using Next Generation Sequencing (NGS).	Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Secondary	Activation Time	Activation Time in Seconds.	At the time of procedure, up to 1 hour
Secondary	Procedure Time	Procedure Time Seconds.	At the time of procedure, up to 1 hour