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Cryotherapy

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (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
No Placebo-Only Group

Summary

This trial is testing a new small, flexible tool that uses cold to take lung tissue samples. It aims to provide better quality samples with fewer complications for patients undergoing lung biopsies. This new technique is designed to obtain larger and artifact-free lung tissue samples compared to traditional methods.

Eligible Conditions
  • Lung Disease

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,332 Previous Clinical Trials
14,874,849 Total Patients Enrolled
Erbe USA IncorporatedOTHER
11 Previous Clinical Trials
1,200 Total Patients Enrolled
Lonny YarmusPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
45 Total Patients Enrolled
~9 spots leftby Dec 2025
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