NCT05751278

Cryoprobe Versus Forceps for Transbronchial Biopsy

A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of transbronchial biopsy done by a 1.1mm cryoprobe versus the standard 2.0mm forceps.

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. For this study, patients will be randomized in a 1:1 fashion to transbronchial biopsy using a 1.1 mm cryoprobe versus 2.0 mm forceps, stratified by indication (evaluation of lung transplant allograft, diffuse parenchymal lung disease or pulmonary parenchymal lesion). Blinding of the proceduralist is not possible due to the nature of the procedure. Pathologists interpreting the biopsy samples will be blinded to the biopsy device used. 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
DEVICE	Radial Jaw 4 Pulmonary Biopsy Forceps	Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-03-02
• Completion: 2026-03-02
• First posted: 2023-03-02
• Last updated: 2026-04-03

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study