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NCT05311345 Clinical Trial

Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

Interstitial Lung Disease Clinical Trial

Official title:
Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05311345
Other study ID # Cryobiopsy 250
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 6, 2015
Est. completion date April 1, 2020

Study information
Verified date March 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date April 1, 2020
Est. primary completion date September 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18years of age - suspected of Interstitial lung Disease - cryobiopsies performed. Exclusion Criteria: - FVC below 50% of predicted - DLCO below 35% - Body Mass Index (BMI) above 35 - pulmonary hypertension with a tricuspidal gradient above 40 mmHg - other cardiac or other comorbidities that would increase the risk of complications

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumothorax Pneumothorax, hemorrhage, acute exacerbation and death 2 weeks
Primary Hemorrhage Hemorrhage during the procedure 3 days
Primary Acute exacerbation Acute exacerbation after the procedure 100 days
Primary Mortality Mortality after the procedure 100 days
Secondary Diagnostic yield Diagnostic yield is discussed at multidisciplinary team meetings i.e, adequate biopsies (>50% alveolated biopsies), histologic pattern, kontribution to the diagnosis. 1 month
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