NCT04486560

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique (The FROSTBITE Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe. This study does not involve randomization or assigning different patients to different procedures to compare. Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only difference from the standard of care approach is that the physician performing the transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe. Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.

Conditions

• Lung Diseases

Interventions

Type	Name	Description
DEVICE	ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651	ERBE 1.1mm flexible single-use cryoprobe with oversheath

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-11-29
• Completion: 2022-01-31
• First posted: 2020-07-24
• Last updated: 2022-02-25
• Results posted: 2022-02-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study