DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRocco Bilancia
About this trial
Surgical division of fissure is hypothesized to be safe and feasible. However, there is no preparatory study to test this hypothesis. It is logically expected that morbidity from the procedure could be less than standard LVRS and in preparation to a side-to-side trial of fissure division versus standard LVRS, a safety and feasibility study is required to test this hypothesis and inform future trial design.
Eligibility criteria
Qualifiers
Age < or equal 75 years
Stable COPD with less than or equal to 10mg prednisolone daily
Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration
Willing and able to complete protocol required study follow-up assessments and procedures
Disqualifiers
Fissure completeness <90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided)
Chartis positive for collateral ventilation or not performed/not satisfactory at initial EBLVR
Quantitative perfusion of target lobe >25% of total on SPECT assessment.
Previous lung surgery or pleurodesis on the target side for LVR.
Trial design
Treatments tested in this trial
- Surgical Lung Fissure Division
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Rocco Bilancia
Lead sponsor
Golden Jubilee National Hospital
Sponsor institution
Source ClinicalTrials.gov