Spiration Valve System 9 mm European Post Market Evaluation Study

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03008226
• Other study ID #: TKSPI 001/2014
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2016
• Last updated: December 29, 2016
• Start date: June 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2016
• Source: Heidelberg University
• Contact: Felix Herth, Prof.
• Phone: +49(0)6221/3961201
• Email: herth[@]uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patient is older than 40 years in age

• Patient has severe heterogeneous emphysema with moderate to severe dyspnea as defined as an mMRC of 2 or greater.

• The target lobe and ipsilateral lobe will be separated with an intact fissure, as determined by HRCT (> 90% integrity).

• Patient has received standard-of-care medical management and it has been stable for 6 weeks.

• Patient can walk a minimum of 140 meters in the six minute walk test.

• Patient's obstructive disease is severe as defined by: FEV1 =45% of predicted

• Patient's hyperinflation is defined by: RV = 150% of predicted

• Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period

Exclusion Criteria:

• Patient does not have at least one airway with the intention to be treated with a 9 mm Spiration Valve based on a calibrated balloon sizing of the airway.

• Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study

• Patient is unable to provide informed consent

• Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures

• Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the 3 months prior to baseline testing.

• Patient has giant bulla (> 1/3 volume of lung)

• Patient has severe pulmonary hypertension.

• Patient has bronchiectasis

• Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period

• Patient has had prior lung volume reduction surgery, intra-bronchial valve therapy for emphysema, or major lung procedures (lobectomy or greater).

• Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.

• Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Implementation of 9 mm intrabronchial valves

Locations

Country	Name	City	State
Germany	Thoraxklinik, University of Heidelberg	Heidelberg

Sponsors (4)

Lead Sponsor	Collaborator
Heidelberg University	Asklepios Kliniken Hamburg GmbH, Lung Clinic Hemer, Otto Wagner Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean changes in target lobe volume		180 days	Yes