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A Prospective, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema

A Prospective, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema - The Spiration IBV Valve system study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30950
Enrollment
10
Registered
2007-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe emphysema

Interventions

All study subjects will be evaluated and tested at the same intervals, i.e., baseline, 1 month, 3 months, and 6 months. During the bronchoscopic procedure, to be performed on study Day 0, study subj

Sponsors

Spiration Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subject is between 40 and 74 years of age. Subject has predominantly upper lobe, emphysema and severe dyspnea.

Exclusion criteria

Exclusion criteria: Subjects with FEV1 and DLCO

Design outcomes

Primary

MeasureTime frame
The study outcome will be the difference between the response rates of the treatment and control groups in disease-related health status as measured by the St. George*s Respiratory Questionnaire (SGRQ) total score and lung volume change as measured by CT scan at 3 months.—

Secondary

MeasureTime frame
No secundary study parameters.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)