Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique

NCT04486560 | Completed Results DMC FDA Device

• 1 other identifier: IRB00235679
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

lung; cryoprobe; bronchoscopic; biopsy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serious Adverse Events

  The number of participants enrolled who experienced a device related Serious Adverse Events (SAEs). SAEs include Grade 3-4 bleeding (bleeding causing cardiopulmonary instability or requiring inflation of a bronchial blocker), pneumothorax requiring chest tube placement (Grade 2+), or 30-day respiratory failure and death.

  Within 30 days of procedure

Secondary Outcomes (10)

• Number of Participants With Minor Adverse Events

  Within 30 days of procedure

• Mean Histologic Accessibility Grade

  Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)

• Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis

  During procedure, up to 1 hour

• Total Histologic Area (Square Millimeters)

  Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)

• Alveolated Area (Square Millimeters)

  Data assessed at the time of review of biopsy sample (up to one year post index procedure) and participants were assessed for the outcome measure at the time of biopsy procedure (up to 1 hour)

Study Arms (1)

Single Arm: Cryoprobe

EXPERIMENTAL

Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe.

Device: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Interventions

ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 DEVICE

ERBE 1.1mm flexible single-use cryoprobe with oversheath

Single Arm: Cryoprobe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, ≥ 18-years-old
• Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist

You may not qualify if:

• Pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment
• Individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 110 mmHg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months)
• Presence of bleeding disorder
• Platelet count \<50,000
• Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
• International Normalized Ratio (INR) \<1.5
• Robotic Bronchoscopy

Sponsors & Collaborators

• Johns Hopkins University: lead
• Erbe USA Incorporated: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21218, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Limitations and Caveats

All procedures were performed at large academic centers so procedural volume and pathology may not be generalizable. Larger proportion of lung transplant patients enrolled means there is a lack of heterogeneity in disease entities. Study aimed to address safety so the design and sample size is too small to accurately estimate diagnostic yield. Sheath was required for all cases, precluding use of robotic-assisted bronchoscopy (and underrepresentation of lung cancer).

Results Point of Contact

• Title: Dr. Lonny Yarmus
• Organization: Johns Hopkins University

lyarmus@jhmi.edu

410-502-5224

Study Officials

• Lonny Yarmus

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, non-randomized, single-arm, prospective trial. Therefore, all participants will have their transbronchial biopsy with the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 7, 2020
• Primary Completion: November 29, 2021
• Study Completion: January 31, 2022
• Last Updated: February 25, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)