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.
Device: Implementation of 9 mm intrabronchial valves
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Full eligibility criteria for NCT03008226
Ages eligible for Study
40 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT03008226
Thoraxklinik, University of Heidelberg
Heidelberg, Germany, 69126
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Tris trial is registered with FDA with number: NCT03008226. The sponsor of the trial is Heidelberg University and it is looking for 120 volunteers for the current phase.
Official trial title: Post Market Evaluation of the 9mm Spiration Valve System in Patients With Severe Heterogeneous Emphysema
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