Interlobar fissure completion and pleural adhesiolysis for Chronic Obstructive Pulmonary Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Beth Israel Deaconess Medical Center, Boston, MAChronic Obstructive Pulmonary DiseaseInterlobar fissure completion and pleural adhesiolysis - Procedure
Study Summary
This trial will compare the effects of the experimental intervention (lung fissure completion with adhesiolysis) to the standard of care (EBVs therapy) in patients with severe emphysema/COPD who have failed bronchoscopic lung volume reduction.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 2 years
2 years
Incidence of severe adverse events
Percentage of patients to achieve target lung volume reduction
Percentage of patients with quality of life improvement
Percentage of patients with significant changes in pulmonary function testing
Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Fissure completion and adhesiolysis arm
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Interlobar fissure completion and pleural adhesiolysis · No Placebo Group · N/A
Fissure completion and adhesiolysis arm
Procedure
Experimental Group · 1 Intervention: Interlobar fissure completion and pleural adhesiolysis · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
782 Previous Clinical Trials
846,079 Total Patients Enrolled
Eligibility Criteria
Age 40 - 75 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You still have endobronchial valves (EBV) in your lungs.
You have recently received a vaccine for pneumococcus.
You have had a flu shot recently.
References
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Frequently Asked Questions
Are there any stipulations for participation in this trial?
"This medical experiment is enrolling 20 patients aged 40-75 with emphysema who must meet the following conditions: taking no more than 10mg of prednisone daily, not having smoked in four months and willing to abstain from smoking during the trial duration, pneumococcal vaccination up to date, current flu shot, pre-specified lung volume reduction post BLVR <350ml., MMRC score >2 after BLVR procedure., Endobronchial valves still present,, capacity for study visits/procedures." - Anonymous Online Contributor
Unverified Answer
What is the current enrollment of participants in this medical trial?
"Affirmative. Clinicaltrials.gov exhibits that this clinical trial, which commenced on May 24th 2022, is presently looking for participants. Approximately 20 patients need to be enrolled from 1 medical centre." - Anonymous Online Contributor
Unverified Answer
Are there any openings for volunteers to join this research project?
"Affirmative. Clinicaltrials.gov contains data which indicates that this study is presently in the process of recruiting participants, with 20 individuals sought from a single clinical trial site since its original posting on May 24th 2022 and subsequent update on June 10th 2022." - Anonymous Online Contributor
Unverified Answer
Does the trial's criteria include individuals of advanced age?
"This clinical trial will only accept patients between 40 and 75 years of age. For those younger than 18 or older than 65, there are 30 ancillary studies accepting participants." - Anonymous Online Contributor
Unverified Answer