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The Spiration Valve System for the Treatment of Severe Emphysema

NCT01989182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-02-14

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Conditions

  • Empyhsema
  • Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Spiration Valve System

OTHER

Medical Management

Sponsors & Collaborators

  • Olympus Corporation

    collaborator INDUSTRY

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Nanshan Zhong, MD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-08
Primary Completion
2016-05-18
Completion
2017-03-31

Countries

  • China

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 NCT01989182 on ClinicalTrials.gov