Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
NCT04486560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2022-02-25
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.
Conditions
- Lung Diseases
Interventions
- DEVICE
-
ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651
ERBE 1.1mm flexible single-use cryoprobe with oversheath
Sponsors & Collaborators
-
Erbe USA Incorporated
collaborator OTHER - lead OTHER
Principal Investigators
-
Lonny Yarmus · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-07
- Primary Completion
- 2021-11-29
- Completion
- 2022-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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