NCT07682168Not yet recruiting
DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Rocco Bilancia
- Diseases
- COPD
- NCT number
- NCT07682168
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Aug 2026 to the primary completion date, 31 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous lung surgery or pleurodesis on the target side for LVR.
Other illness
- Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (\<12mo)
- Myocardial infarction within 6 months of screening.
Lab values
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (\<12mo)
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
Other
- 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.
- Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day.
- More than 3 COPD exacerbation episodes in the last year.
- Evidence of hypercapnia (pCO2 \>7KPa) - ABG to be performed on admission for index procedure
Who the study is looking for
- 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
- Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment)
- Recent (\< 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by:
- Persistent symptomatic dyspnoea (mMRC \>2) which in the patient's view is no better than baseline
- Absence of target lobar collapse with any residual aeration apparent on imaging
- Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.