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Cryotherapy

ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 for Lung Disease (FROSTBITE Trial)

N/A
Waitlist Available
Led By Lonny Yarmus
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 data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
Awards & highlights

FROSTBITE Trial Summary

This study is evaluating whether a new type of biopsy tool is safe and effective.

FROSTBITE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)
This trial's timeline: 3 weeks for screening, Varies for treatment, and data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Serious Adverse Events
Secondary outcome measures
Activation Time (Seconds)
Alveolated Area (Square Millimeters)
Artifact Free Lung Parenchyma Percent
+7 more

FROSTBITE Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm: CryoprobeExperimental Treatment1 Intervention
Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.
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?

Johns Hopkins UniversityLead Sponsor
2,283 Previous Clinical Trials
14,842,421 Total Patients Enrolled
Erbe USA IncorporatedOTHER
10 Previous Clinical Trials
1,100 Total Patients Enrolled
Lonny YarmusPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
45 Total Patients Enrolled
~10 spots leftby Jun 2025
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