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RISA Extension Study - Long Term Safety

NCT00401986 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2021-02-01

Study results available
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Summary

The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).

Conditions

Interventions

DEVICE

Bronchial thermoplasty with the Alair System

Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Narinder S Shargill, PhD · Asthmatx, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-12-31
Completion
2011-02-28
FDA Device
Yes

Countries

  • Brazil
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00401986 on ClinicalTrials.gov