Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1)
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|ClinicalTrials.gov Identifier: NCT05257681|
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : June 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Emphysema or COPD||Procedure: Interlobar fissure completion and pleural adhesiolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is expected to enroll a total of 20 subjects with a follow-up period of 3 months. All interventions and follow-up will be performed at the BIDMC. In current medical practice, emphysema patients that fail to achieve target lung volume reduction after endobronchial valves placement, are continued on current medical management for their COPD, with consideration for lung transplantation should they be eligible depending on clinical circumstances and degree of lung function impairment. The investigators plan to offer this patient population the possibility to undergo a VATS fissure completion and adhesiolysis.|
|Masking:||None (Open Label)|
|Official Title:||Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction|
|Actual Study Start Date :||May 24, 2022|
|Estimated Primary Completion Date :||May 24, 2024|
|Estimated Study Completion Date :||May 24, 2024|
Experimental: Fissure completion and adhesiolysis arm
Patients will undergo a VATS or robotic interlobar lung fissure completion with pleural adhesiolysis. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.
Procedure: Interlobar fissure completion and pleural adhesiolysis
A video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.
- Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction [ Time Frame: 2 years ]The investigators will determine that performing the surgery is feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled.
- Incidence of severe adverse events [ Time Frame: 2 years ]The investigators will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.
- Percentage of patients to achieve target lung volume reduction [ Time Frame: 2 years ]Describe the percentage of patients that achieve target lung volume reduction of at least 350mL at three months after the procedure.
- Percentage of patients with quality of life improvement [ Time Frame: 2 years ]Describe the changes in quality of life based on three subjective questionnaires that will be given to patients at baseline and three months after the intervention.
- Percentage of patients with significant changes in pulmonary function testing [ Time Frame: 2 years ]Describe the changes in PFTs after the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05257681
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Adnan Majid, MD FCCP 617-632-8252 email@example.com|
|Principal Investigator: Adnan Majid, MD FCCP|