At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)
In Brief
A clinical study evaluating ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 for Lung Diseases. Completed, enrolled 51 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bronchoscopic approach.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases
CountriesUnited States
CollaboratorsErbe USA Incorporated
Timeline
N/ACompletedFinished
202120222023202420252026
Enrollment StartJul 2020
First PostedJul 2020
Primary CompletionNov 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJul 24, 2020
Enrollment StartJul 7, 2020
Primary CompletionNov 29, 2021
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.9 years ago
Interventions
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651device
ERBE 1.1mm flexible single-use cryoprobe with oversheath