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

NCT03685526 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-29

No results posted yet for this study

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.

Conditions

  • Emphysema

Interventions

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.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Felix Herth · Thoraxklinik-Heidelberg gGmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-10-01
Completion
2022-08-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685526 on ClinicalTrials.gov