Cryoprobe Versus Forceps for Transbronchial Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cryoprobe

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe

Group Type EXPERIMENTAL

ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Intervention Type DEVICE

ERBE 1.1mm flexible single-use cryoprobe with oversheath

Forceps

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps

Group Type ACTIVE_COMPARATOR

Radial Jaw 4 Pulmonary Biopsy Forceps

Intervention Type DEVICE

Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope

Interventions

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ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

ERBE 1.1mm flexible single-use cryoprobe with oversheath

Intervention Type DEVICE

Radial Jaw 4 Pulmonary Biopsy Forceps

Radial Jaw 4 Pulmonary Biopsy Forceps Standard Capacity for 2mm endoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or Female, ≥ 18-years-old
* Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care

Exclusion Criteria

* Pregnant or nursing woman or woman of child-bearing potential who refuse to take a pregnancy test prior to enrollment
* Severe pulmonary hypertension (RVSP \> 60 mmHg)
* Stroke within the last 6 months or myocardial infarction within the last 3 months
* Presence of bleeding disorder
* Platelet count \< 50,000 per mL at time of enrollment
* Use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended time prior to invasive procedure (aspirin monotherapy is acceptable)
* Do Not Resuscitate (DNR) status
* Do Not Intubate (DNI) status

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No