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STRIVE Post-Market Registry Study

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Overview

This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.

Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Clinical Trial Information

Protocol

TIRB#: 26350

Phase

N/A

Condition(s)

Chronic Obstructive Pulmonary Disease (COPD), Emphysema

Investigator

Gerard Criner, MD

Coordinator

Helga Criner

Visit clinicaltrials.gov for full description.

Contact

For more information about this trial or to inquire about eligibility, email [email protected] or call 215-707-1359.

Full Title

The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema