Cinenses Lung Volume Reduction Reverser System First-in-man Study Treating Patients With Severe Emphysema

Not Applicable

• Conditions: Emphysema
• Interventions: Device: Cinenses Lung Volume Reduction Reverser System

• Registration Number: NCT03685526
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Study Start: 2019-05-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-29
• Primary Completion: 2021-10-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Cinenses Lung Volume Reduction Reverser System	Patients will be treated with Cinenses Lung Volume Reduction Reverser System.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	3-month post final bronchoscopy	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.

Secondary Outcome Measures

Name	Time	Method
Device success (Device level)	immediate postoperative	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.
Procedural success	during the hospital stay	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
Improvement in the mMRC dyspnea scale	1,3,6-month,12-month follow-up	Improvement in the mMRC dyspnea scale from baseline (Pre-Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
St. George's Respiratory Questionnaire (SGRQ) score	1,3,6-month,12-month follow-up	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.
Percent change in forced expiratory volume in 1 second	1,3,6-month,12-month follow-up	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.
Decrease in the Residual Volume (RV)	1,3,6-month,12-month follow-up	Decrease in the Residual Volume (RV) from baseline (Pre-Treatment Visit) compared to; 1-, 3- and 6-month,12-month follow-up.
Improvement in the 6-minute walk test	1,3,6-month,12-month follow-up	Improvement in the 6-minute walk test from baseline (Pre-Treatment Visit) compared to; 1-, 3- and 6-month,12-month follow-up

Trial Locations

Locations (1)

Thoraxklinik am Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany