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Tests treatment safety and results for Mediastinal Lymphadenopathy
Official title Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy
ClinicalTrials.gov ID: NCT07301697
What this study is testing
- What it's testing
- Transbronchial cryobiopsy is a relatively recent technique, increasingly used for the diagnosis of various respiratory diseases, including neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is included in European recommendations for the diagnosis of interstitial lung diseases.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients who have undergone, or are eligible for, a cryobiopsy according to national or international recommendations, or after failure of a...
- Procedure performed within the bronchial endoscopy department of the New Civil Hospital of the University Hospitals of Strasbourg.
- For diffuse interstitial lung diseases: decision to perform a transbronchial cryobiopsy after case review in a multidisciplinary consultation meeting...
- For lymph node puncture (EBUS-cryobiopsy): after discussing the case in a multidisciplinary concentration meeting, in patients with a lesion and/or...
- For the retrospective analysis: all patients who underwent a cryobiopsy, and those who had a CT-guided lung biopsy for diagnostic assessment of an...
You likely can't join if
- \- Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, or legal protection.
- Patients at increased risk of bleeding: patients on anticoagulants not stopped for 24 hours, or on direct oral anticoagulants not stopped for 5 days...
- Saturation below 90% on oxygen therapy with a maximum allowable flow of 2 L/min.
- Pre-existing severe heart disease: unstable angina, myocardial infarction, decompensated heart failure.
See the full eligibility criteria
- All patients who have undergone, or are eligible for, a cryobiopsy according to national or international recommendations, or after failure of a first diagnostic test followed by a collegial discussion regarding the...
- Procedure performed within the bronchial endoscopy department of the New Civil Hospital of the University Hospitals of Strasbourg.
- For diffuse interstitial lung diseases: decision to perform a transbronchial cryobiopsy after case review in a multidisciplinary consultation meeting for patients whose specific type of ILD could not be determined with...
- For lymph node puncture (EBUS-cryobiopsy): after discussing the case in a multidisciplinary concentration meeting, in patients with a lesion and/or mediastinal adenopathy, as a second- or third-line procedure, following...
- For the retrospective analysis: all patients who underwent a cryobiopsy, and those who had a CT-guided lung biopsy for diagnostic assessment of an ILD or evaluation of suspected pulmonary neoplasm, since July 2024.
- \- Patients under 18 years of age.
- Pregnant or breastfeeding women.
- Patients under guardianship, curatorship, or legal protection.
- Patients at increased risk of bleeding: patients on anticoagulants not stopped for 24 hours, or on direct oral anticoagulants not stopped for 5 days, or with INR \> 1.5 for patients on VKAs and heparin. Patients on dual...
- Saturation below 90% on oxygen therapy with a maximum allowable flow of 2 L/min.
- Pre-existing severe heart disease: unstable angina, myocardial infarction, decompensated heart failure.
- Known pulmonary hypertension with systolic pulmonary arterial pressure above 50 mmHg on transthoracic echocardiography.
- Inability to provide the subject with informed information (emergency situation, subject has difficulty understanding, etc.)
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.