The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness.
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness. Study Population :Patients with severe emphysema and have to meet all the inclusion and exclusion criteria. Sample Size: 15 subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Lung Volume Reduction Reverser System is show as figure 1-4, consists of lung volume reduction reverser (short as: reverser), conveyor, measuring guide wire and transporting sheath. Matrix of reverser is nickel titanium alloy, its surface is coated by polymer flexible film, at the end of the connection segment is specially designed connector, which is easy for the reverser's transport and recycling. The silica gel part at the far end of reverser makes it softer.
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Incidence of adverse events
Evaluate adverse events associated with implantation of the Cinenses Lung Volume Reduction Reverser System at 3-month post final bronchoscopy. CinensesTMLung Volume Reduction Reverser System at 3-month post final bronchoscopy.
Time frame: 3-month post final bronchoscopy
Device success (Device level)
Device success was defined as successful delivery and deployment of the study device at the intended target position and successful withdrawal of the delivery system.
Time frame: immediate postoperative
Procedural success
Procedural success was defined as all the study devices that were intended to be used during one procedure were achieved device success and the subject was without the occurrence of device-related or procedure-related SAEs during the hospital stay
Time frame: during the hospital stay
St. George's Respiratory Questionnaire (SGRQ) score
The improvement of St. George's Respiratory Questionnaire (SGRQ) score from baseline (Pre-Treatment Visit) to 1-, 3- and 6-month ,12-month follow-up.
Time frame: 1,3,6-month,12-month follow-up
Percent change in forced expiratory volume in 1 second
Percent change in forced expiratory volume in 1 second (FEV1) from baseline (Pre- Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
Time frame: 1,3,6-month,12-month follow-up
Decrease in the Residual Volume (RV)
Decrease in the Residual Volume (RV) from baseline (Pre-Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
Time frame: 1,3,6-month,12-month follow-up
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Improvement in the 6-minute walk test
Improvement in the 6-minute walk test from baseline (Pre-Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up
Time frame: 1,3,6-month,12-month follow-up
Improvement in the mMRC dyspnea scale
Improvement in the mMRC dyspnea scale from baseline (Pre-Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
Time frame: 1,3,6-month,12-month follow-up