Trials / Unknown
UnknownNCT03685526
Cinenses Lung Volume Reduction Reverser System First-in-man Study Treating Patients With Severe Emphysema
Evaluation of the Cinenses Lung Volume Reduction Reverser System in Treating Patients With Severe Emphysema
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cinenses Lung Volume Reduction Reverser System | 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. |
Timeline
- Start date
- 2019-05-06
- Primary completion
- 2021-10-01
- Completion
- 2022-08-01
- First posted
- 2018-09-26
- Last updated
- 2021-06-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03685526. Inclusion in this directory is not an endorsement.