Cryoprobe Versus Forceps for Transbronchial Biopsy (FROSTBITE-2)

Johns Hopkins University

Status: Active, not recruiting

Conditions: Lung Diseases

Treatments: Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651; Device: Radial Jaw 4 Pulmonary Biopsy Forceps

Study type: Interventional

Funder types: Other

Identifiers

NCT05751278

IRB00344800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Cryoprobe

Experimental group

Description:

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe

Treatment:

Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Forceps

Active Comparator group

Description:

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps

Treatment:

Device: Radial Jaw 4 Pulmonary Biopsy Forceps