Cryoprobe Versus Forceps for Transbronchial Biopsy
FROSTBITE-2
A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy
1 other identifier
interventional
500
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2026
CompletedMarch 27, 2026
March 1, 2026
3 years
February 20, 2023
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (12)
Histological Accessibility grade of the biopsy specimen
Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Bleeding Complication Rate
Within 30 days of procedure
Pneumothorax Complication Rate
Within 30 days of procedure
Post-Procedure Respiratory Failure Rate
Within 30 days of procedure
Number of deaths
Within 30 days of procedure
- +7 more secondary outcomes
Study Arms (2)
Cryoprobe
EXPERIMENTALParticipants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe
Forceps
ACTIVE COMPARATORParticipants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps
Interventions
Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope
ERBE 1.1mm flexible single-use cryoprobe with oversheath
Eligibility Criteria
You may qualify if:
- Male or Female, ≥ 18-years-old
- Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erbe USA Incorporatedcollaborator
- Johns Hopkins Universitylead
Study Sites (9)
Northwestern Medicine
Chicago, Illinois, 60611, United States
University of Maryland, Baltimore (UMB)
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Washington University in Saint Louis (Wash-U)
St Louis, Missouri, 63130, United States
NYU Langone Health
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Thiboutot, MD, MHS
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 2, 2023
Study Start
February 27, 2023
Primary Completion
March 2, 2026
Study Completion
March 2, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share