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NCT05628415
Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema
Conditions: Postoperative Air Leak, Lung Resection
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: University Hospital, Basel, Switzerland
Location: Switzerland
Summary
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema.
The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.
Eligibility Criteria
Inclusion Criteria:Informed Consent signed by the subjectPatients discussed in the interdisciplinary emphysema treatment board and found to have the indication for a LVRS or patients who meet the criteria in agreement with pneumology recommendation for bilateral or unilateral LVRS with pulmonary emphysema (all morphologies including chronic obstructive pulmonary disease (COPD) GOLD III and IV) or patients operated for other Pathology other than lung emphysema requiring lung resection in the presence of severe lung emphysema.Exclusion Criteria:non-bullous pulmonary emphysemaSeverely impaired carbon monoxide diffusing capacity (≤ 20% of predicted value, One-second capacity (FEV1) ≤ 20% of predicted value with a homogeneous emphysema morphologyPatients with severe pulmonary arterial hypertension (> 35 mHg)Significant (i.e.
clinically relevant and symptomatic) Coronary Arterial Disease (CAD)Inability to follow the procedures of the study, e. g. due to language problems, psychological disorders, dementia, etc. of the participantEnrolment of the investigator, his/her family members, employees and other dependent personCurrent enrolment in another clinical trial studying an experimental treatmentPregnancy
Source: ClinicalTrials.gov (NCT05628415). StuddyBuddy aggregates publicly available trial information.