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Completed

NCT Number: NCT04486560

Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

Device

ERBE 1.1mm flexible single-use cryoprobe with oversheath

Primary outcomes

  1. Number of Participants With Serious Adverse Events

    Time frame: Within 30 days of procedure

    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.

Secondary outcomes

  1. Number of Participants With Minor Adverse Events

    Time frame: Within 30 days of procedure

    The number of participants enrolled who experienced a device related Minor Adverse Event (AE). AEs include Grade 1-2 bleeding (bleeding requiring suction to clear or wedging of the biopsied segment with the flexible bronchoscope and/or iced saline), or pneumothorax not requiring chest tube placement (Grade 1).

  2. Mean Histologic Accessibility Grade

    Time frame: 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)

    Grade 0: Does not contain alveolar structures and can therefore not be assessed

    Grade 1: Very poor specimen quality; not possible to assess the relevant morphologic and histologic features

    Grade 2: Poor specimen quality; assessment of relevant morphologic and histologic structures and features is severely compromised and not possible

    Grade 3: High limitations in specimen quality; assessment is severely compromised but limited evaluation is possible

    Grade 4: Moderate limitations in specimen quality; assessment is moderately compromised but evaluation is possible

    Grade 5: Low limitations in specimen quality; assessment is somewhat compromised but possible

    Grade 6: The specimen allows for complete and unrestricted assessment of all relevant morphologic and histologic structures and features

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

    Time frame: During procedure, up to 1 hour

    Diagnostic yield is defined as number of patients for which cryobiopsy led to a diagnosis. Diagnostic yield will be determined from the results of cryobiopsy specimen only. A biopsy that results in a specific diagnosis, either malignant or benign (granuloma, inflammation, fibrosis, infection) will be assumed to be a true positive. Atypia, minimal inflammation or lung parenchyma without pathologic findings on final pathology reads are considered non-diagnostic.

  4. Total Histologic Area (Square Millimeters)

    Time frame: 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)

    Amount of total histologic tissue in square millimeters observed under microscope.

  5. Alveolated Area (Square Millimeters)

    Time frame: 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)

    Total amount of area in square millimeters containing alveoli.

  6. Open Alveoli Percent

    Time frame: 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)

    Percentage of all alveoli that are open.

  7. Percent Crush Artifact

    Time frame: 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)

    Percent of tissue distortion resulting from even the minimal compression of the tissue, which may rearrange tissue morphology.

  8. Artifact Free Lung Parenchyma Percent

    Time frame: 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)

    Percent of the lung parenchyma (alveoli, alveolar ducts and respiratory bronchioles) without artifact.

  9. Activation Time (Seconds)

    Time frame: At the time of procedure, up to 1 hour

    Time of activation of cryoprobe.

  10. Procedure Time

    Time frame: At the time of procedure, up to 1 hour

    Time for entire procedure measured in minutes.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Erbe USA Incorporated

Registry information

Official study title

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

Acronym: FROSTBITE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 24, 2020
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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