Lung DiseasesFROSTBITE-2NCT05751278
Cryoprobe Versus Forceps for Transbronchial Biopsy
A study testing ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 and Radial Jaw 4 Pulmonary Biopsy Forceps in people with Lung Diseases, run by Johns Hopkins University at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 and Radial Jaw 4 Pulmonary Biopsy Forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Feb 2023to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, ≥ 18-years-old
- Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland, Baltimore (UMB)
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
The Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Medicine
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University in Saint Louis (Wash-U)
St Louis, Missouri, 63130
About this study
Official title: A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy
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.
Read the detailed 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.
- Conditions
- Lung Diseases
- Being tested
- ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651, Radial Jaw 4 Pulmonary Biopsy Forceps
- Keywords
- lung, cryoprobe, bronchoscopic, biopsy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651Device
ERBE 1.1mm flexible single-use cryoprobe with oversheath
Radial Jaw 4 Pulmonary Biopsy ForcepsDevice
Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope
| Study group | Role | What they receive |
|---|---|---|
| Cryoprobe | Experimental | Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe Receives: Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 |
| Forceps | Active comparator | Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps Receives: Device: Radial Jaw 4 Pulmonary Biopsy Forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure, up to 1 hour
Secondary outcomes (15)
Histological Accessibility grade of the biopsy specimen
7-point Likert scale: 0-6 with 0 being worse and 6 being best.
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Bleeding Complication Rate
Number of occurrences of bleeding (grade ≥ 3 modified CTCAE).
Measured: Within 30 days of procedure
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.
Measured: 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.
Measured: 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.
Measured: During procedure, up to 1 hour
Pneumothorax Complication Rate
Number of occurrences of pneumothorax requiring chest tube placement (grade ≥ 2, CTCAE).
Measured: Within 30 days of procedure
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).
Measured: Within 30 days of procedure
Number of deaths
Number of occurrences of death.
Measured: Within 30 days of procedure
Total Histologic Area
Total Histologic Area in Square Millimeters.
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Alveolated Area
Alveolated Area Square Millimeters
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Percent Crush Artifact
Percent total area for Crush Artifact.
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Artifact-free lung parenchyma
Percent Artifact-free lung parenchyma.
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Adequacy for Molecular Testing
Assessed as a yes or no using Next Generation Sequencing (NGS).
Measured: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Activation Time
Activation Time in Seconds.
Measured: At the time of procedure, up to 1 hour
Procedure Time
Procedure Time Seconds.
Measured: At the time of procedure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start27 Feb 2023
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Sponsor
- Investigators
- Jeffrey Thiboutot, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751278
- Sponsor's protocol ID
- IRB00344800
- Acronym
- FROSTBITE-2
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thiboutot J, Kapp CM, Illei P, Shofer S, Gilbert CR, DiBardino D, DeMaio A, Sethi S, Wahidi MM, Benn BS, Gillespie C, Salmon C, Angel L, Sachdeva A, Holden VK, Paez R, Duke JD, Lentz RJ, Vachani A, Pastis N, Molena D, Tackett S, Jones MR, Rahman NM, Silvestri G, Maldonado F, Yarmus L; Interventional Pulmonary Outcomes Group. Cryobiopsy vs Forceps for Bronchoscopic Lung Biopsy: The FROSTBITE-2 Randomized Clinical Trial. JAMA. 2026 Jun 16;335(23):2038-2045. doi: 10.1001/jama.2026.7908.
PubMed 42149700
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy
- ClinicalTrials.gov ID
- NCT05751278
- Acronym / sponsor ID
- FROSTBITE-2 / IRB00344800
- Conditions
- Lung Diseases
- Keywords
- lung, cryoprobe, bronchoscopic, biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoprobe | Experimental | Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe |
| Forceps | Active comparator | Device: Radial Jaw 4 Pulmonary Biopsy ForcepsParticipants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female, ≥ 18-years-old
- Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651ERBE 1.1mm flexible single-use cryoprobe with oversheath | Device | Cryoprobe |
| Radial Jaw 4 Pulmonary Biopsy ForcepsRadial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope | Device | Forceps |
Primary outcome
Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
Time frame: During procedure, up to 1 hour
Diagnostic Yield as Assessed by Number of Patients for Which the Procedure [Cryobiopsy or Forceps] Led to a Diagnosis.
15 secondary outcomes
Histological Accessibility grade of the biopsy specimen
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Bleeding Complication Rate
Time frame: Within 30 days of procedure
Diagnostic yield for pulmonary parenchymal lesions
Time frame: During procedure, up to 1 hour
Diagnostic yield for diffuse parenchymal lung disease
Time frame: During procedure, up to 1 hour
Diagnostic yield for Lung Transplant
Time frame: During procedure, up to 1 hour
Pneumothorax Complication Rate
Time frame: Within 30 days of procedure
Post-Procedure Respiratory Failure Rate
Time frame: Within 30 days of procedure
Number of deaths
Time frame: Within 30 days of procedure
Total Histologic Area
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Alveolated Area
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Percent Crush Artifact
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Artifact-free lung parenchyma
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Adequacy for Molecular Testing
Time frame: Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Activation Time
Time frame: At the time of procedure, up to 1 hour
Procedure Time
Time frame: At the time of procedure, up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 42149700Thiboutot J, Kapp CM, Illei P, Shofer S, Gilbert CR, DiBardino D, DeMaio A, Sethi S, Wahidi MM, Benn BS, Gillespie C, Salmon C, Angel L, Sachdeva A, Holden VK, Paez R, Duke JD, Lentz RJ, Vachani A, Pastis N, Molena D, Tackett S, Jones MR, Rahman NM, Silvestri G, Maldonado F, Yarmus L; Interventional Pulmonary Outcomes Group. Cryobiopsy vs Forceps for Bronchoscopic Lung Biopsy: The FROSTBITE-2 Randomized Clinical Trial. JAMA. 2026 Jun 16;335(23):2038-2045. doi: 10.1001/jama.2026.7908.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Thiboutot, MD, MHS principal investigator
Johns Hopkins University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 and Radial Jaw 4 Pulmonary Biopsy Forceps in people with Lung Diseases, run by Johns Hopkins University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis (time frame: During procedure, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.