Actively Recruiting
Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
Led by University Hospital, Strasbourg, France · Updated on 2026-01-15
30
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and diagnostic performance of transbronchial cryobiopsy and EBUS-cryobiopsy in patients with various respiratory diseases such as mediastinal lymphadenopathy, mediastinal lesions, and diffuse interstitial lung diseases (ILDs). This study is the first French prospective investigation focusing on these procedures performed by experienced operators in a university hospital setting to reduce variability and improve data on their usefulness and safety. The study involves performing transbronchial cryobiopsy or EBUS-cryobiopsy in patients undergoing evaluation for diffuse interstitial lung disease or mediastinal lesions. The procedures follow national and international recommendations and multidisciplinary consultation decisions. Both retrospective data since July 2024 and prospective data over one year will be collected, focusing on procedures conducted by a limited group of expert interventional pulmonologists. Participants will undergo the cryobiopsy procedure in the thoracic endoscopy department, with data collected immediately after intervention to assess diagnostic success and safety. Researchers will evaluate diagnostic performance based on the results obtained and monitor the procedures for adverse events. Participation includes clinical review and follow-up as part of routine care, with all findings contributing to understanding the role of cryobiopsy in respiratory disease diagnosis.
CONDITIONS
Brief Title
Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone or are eligible for cryobiopsy based on national or international recommendations or after a failed first diagnostic test and multidisciplinary discussion
- Procedure performed at the bronchial endoscopy department of the University Hospitals of Strasbourg
- For diffuse interstitial lung diseases: decision to perform transbronchial cryobiopsy after multidisciplinary review when imaging and tests alone are insufficient and surgical biopsy is not suitable
- For lymph node puncture (EBUS-cryobiopsy): performed as a second or third-line procedure after failed prior tests or as a first-line procedure with EBUS-TBNA for suspected lymphoma
- Retrospective analysis includes patients who had cryobiopsy or CT-guided lung biopsy since July 2024
You will not qualify if you...
- Patients under 18 years old
- Pregnant or breastfeeding women
- Patients under legal guardianship or protection
- Patients at increased bleeding risk due to anticoagulants not stopped as required, dual antiplatelet therapy, or low platelet count
- Oxygen saturation below 90% on oxygen therapy exceeding 2 L/min
- Severe heart disease such as unstable angina, recent heart attack, or decompensated heart failure
- Known pulmonary hypertension with systolic pressure above 50 mmHg on echocardiography
- Inability to provide informed consent due to emergency or comprehension difficulties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo transbronchial cryobiopsy or EBUS-cryobiopsy to diagnose respiratory pathologies such as interstitial lung diseases or lymph node lesions.
1 visit (in-person)
Duration - Up to several weeks following the procedure
Participants are monitored after the diagnostic procedure to assess the safety and performance of the cryobiopsy techniques.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Pulmonology Department - NHC Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
M
Michele PORZIO, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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