Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06959056
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. Bilateral lung transplantation at UZ Leuven
4. Indication for transplantation: End stage chronic obstructive pulmonary disease (COPD)
5. Storage of lungs on classic ice, cooled system (LUNGguard® (Paragonix) or X°Port Lung Transport Device (Traferox Technologies Inc.) ) are all permitted
6. Patients that have undergone lung volume reduction or talcage are not a contraindication for participation in the study.
Exclusion Criteria:
1. Unilateral lung transplantation
2. Lobar transplantation
3. Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
4. Combined organ transplantation
5. Chronic opioid use pre-operatively
6. Participation in an interventional Trial with an investigational medicinal product (IMP) or device (IMD) that could potentially influence the post-operative outcomes of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06959056
Study Brief:
Protocol Section:
NCT06959056