N/A
Completed N=51
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique
Source: ClinicalTrials.gov NCT04486560 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants With Serious Adverse Events — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events |
— | — |
| SECONDARY Number of Participants With Minor Adverse Events |
2; 25 | — |
| SECONDARY Mean Histologic Accessibility Grade |
4.9 | — |
| SECONDARY Diagnostic Yield as Assessed by Number of Patients for Which Cryobiopsy Led to a Diagnosis |
23; 16; 1 | — |
| SECONDARY Total Histologic Area (Square Millimeters) |
54.4 | — |
| SECONDARY Alveolated Area (Square Millimeters) |
11.39; 2.47 | — |
| SECONDARY Open Alveoli Percent |
66.48 | — |
| SECONDARY Percent Crush Artifact |
0.5 | — |
| SECONDARY Artifact Free Lung Parenchyma Percent |
90.86 | — |
| SECONDARY Activation Time (Seconds) |
4.2 | — |
| SECONDARY Procedure Time |
22 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04486560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.