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Cryobiopsy vs Forceps Biopsy for Lung Disease (FROSTBITE-2 Trial)
N/A
Waitlist Available
Led By Jeffrey Thiboutot, MD, MHS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of procedure
Awards & highlights
FROSTBITE-2 Trial Summary
This trial compares two methods of taking lung tissue to see which is more effective.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include bleeding at the biopsy site, pain or discomfort from the procedure, risk of infection post-biopsy, and potential complications related to bronchoscopy such as reaction to anesthesia.
FROSTBITE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
Secondary outcome measures
Activation Time
Adequacy for Molecular Testing
Alveolated Area
+12 moreFROSTBITE-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CryoprobeExperimental Treatment1 Intervention
Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe
Group II: ForcepsActive Control1 Intervention
Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
2020
N/A
~60
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Who is running the clinical trial?
Erbe USA IncorporatedOTHER
9 Previous Clinical Trials
601 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,153 Total Patients Enrolled
Jeffrey Thiboutot, MD, MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
338 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a lung biopsy through a bronchoscopy.I cannot stop my blood thinner medication before a surgery as recommended.I am 18 years old or older.I have a bleeding disorder.You have a Do Not Resuscitate (DNR) order in place.Your platelet count is less than 50,000 per milliliter at the time of enrollment.I have not had a stroke in the last 6 months or a heart attack in the last 3 months.I have severe high blood pressure in the lungs.You have a status that says doctors should not put a breathing tube in you.
Research Study Groups:
This trial has the following groups:- Group 1: Forceps
- Group 2: Cryoprobe
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical experiment that individuals can participate in?
"As per the information on clinicaltrials.gov, this study has temporarily ceased recruitment of patients since 2023 February 21st. It was last updated one day prior to that date. Although this specific trial is not currently recruiting participants, 275 other trials are actively enrolling subjects at present."
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