NCT03008226

Spiration Valve System 9 mm European Post Market Evaluation Study

Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial valve treatment in patients with heterogeneous emphysema and to gain further insights and experience on the treatment with this valve size.

Detailed description

This study is designed to evaluate performance of the 9 mm valve system in patients with at least one airway to be treated . Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea are eligible to be evaluated for enrollment in this study. In this study, eligible patients will have severe emphysema in a target lobe with an intact fissure. Patients must be able to tolerate a flexible bronchoscopy procedure. After evaluation of all inclusion and exclusion criteria, with review of the CT data by the core laboratories, patients will be enrolled in the study. The indications for endoscopic reduction of pulmonary volume with intrabronchial valves are presented in various preliminary examinations. The duration of the study is about 7 months for each patient. It involves an examination before the valves are inserted, the valves are inserted within the scope of a bronchoscopy, followed by a follow-up examination directly after the valves are inserted, a follow-up period of at least 3 nights in the appropriate clinic and follow-up visits 14, 30 each , 90 and 180 days after the valves are inserted. The study is expected to enroll up to 30 patients who complete the 6 month follow-up visit at up to 4 sites with up to 15 patients per site.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	Implementation of 9 mm intrabronchial valves

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-08-01
• First posted: 2017-01-02
• Last updated: 2017-01-02

Locations

1 site across 1 country: Germany