Cryobiopsy vs Forceps Biopsy for Lung Disease

(FROSTBITE-2 Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Jeffrey Thiboutot, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares a new method to a standard one for lung biopsies. It targets patients needing lung tissue samples, aiming to improve sample quality and reduce complications. The new method works by freezing and removing tissue, providing larger and higher-quality samples with a good safety and cost-benefit profile.

Research Team

Jeffrey Thiboutot, MD, MHS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 who need a lung biopsy as part of their usual care. It's not for those with bleeding disorders, severe heart or lung conditions, recent strokes or heart attacks, low platelet counts, or women who could be pregnant and won't test. People on certain blood thinners can't join.

Inclusion Criteria

I am scheduled for a lung biopsy through a bronchoscopy.

I am 18 years old or older.

Exclusion Criteria

I cannot stop my blood thinner medication before a surgery as recommended.

I have a bleeding disorder.

You have a Do Not Resuscitate (DNR) order in place.

Treatment Details

Interventions

• Cryoprobe (Procedure)
• Forceps (Procedure)

Trial Overview The study is testing if using a smaller cryoprobe (1.1mm) to take lung tissue samples is as effective as the standard larger forceps (2.0mm). Participants will undergo bronchoscopy where either the cryoprobe or forceps will be used for biopsy.

Participant Groups

Group I: Cryoprobe Experimental Treatment 1 Intervention

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

Group II: Forceps Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Medical Center Durham, NC

NYU Langone Health New York, NY

University of Pennsylvania Philadelphia, PA

Johns Hopkins Hospital Baltimore, MD

More Trial Locations

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+