Spiration Valve System 9 mm European Post Market Evaluation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT03008226
• Date of registration: 29/12/2016
• Prospective Registration: No
• Primary sponsor: Heidelberg University
• Public title: Spiration Valve System 9 mm European Post Market Evaluation Study
• Scientific title: Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema
• Date of first enrolment: June 2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03008226
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Felix Herth, Prof.Dr.med.
• Affiliation: University Heidelberg

• Name: Felix Herth, Prof-

• Name: Felix Herth, Prof.

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Emphysema

Intervention(s)

Device: Implementation of 9 mm intrabronchial valves

Primary Outcome(s)

Mean changes in target lobe volume [Time Frame: 180 days]

Secondary ID(s)

TKSPI 001/2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lung Clinic Hemer

Asklepios Kliniken Hamburg GmbH

Otto Wagner Hospital