- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Felix Herth, Prof.
- Phone Number: +49(0)6221/3961201
- Email: herth@uni-heidelberg.de
Study Locations
-
-
-
Heidelberg, Germany, 69126
- Recruiting
- Thoraxklinik, University of Heidelberg
-
Contact:
- Felix Herth, Prof-
- Phone Number: +49(0)6221/3961201
- Email: herth@uni-heidelberg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean changes in target lobe volume
Time Frame: 180 days
|
180 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felix Herth, Prof.Dr.med., University Heidelberg
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKSPI 001/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emphysema
-
Pulmonx CorporationRecruitingEmphysema or COPD | Emphysema, PulmonarySpain, Germany, Italy
-
Pulmonx CorporationActive, not recruiting
-
Heidelberg UniversityUnknown
-
Royal Brompton & Harefield NHS Foundation TrustCompletedHeterogeneous EmphysemaUnited Kingdom
-
Aeris TherapeuticsCompleted
-
Pulmonx CorporationCompleted
-
University Medical Center GroningenCompletedEmphysema or COPDNetherlands
-
Aeris TherapeuticsCompleted
-
University Medical Center GroningenRecruitingEmphysema or COPDNetherlands
-
Rabin Medical CenterUnknownPatients With Advanced Homogeneous EmphysemaIsrael
Clinical Trials on Implementation of 9 mm intrabronchial valves
-
Heidelberg UniversityTerminatedHereditary Emphysema (Alpha 1-antitrypsin Deficiency)Germany
-
University of North Carolina, Chapel HillMinistry of Public Health, Democratic Republic of the Congo; Kinshasa School... and other collaboratorsCompleted
-
Taipei Veterans General Hospital, TaiwanCompleted
-
Dentsply Sirona Implants and ConsumablesCompletedJaw, Edentulous, PartiallyUnited States