Spiration Valve System 9 mm European Post Market Evaluation Study

NCT03008226 | Unknown

• 1 other identifier: TKSPI 001/2014
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• Mean changes in target lobe volume

  180 days

Interventions

Implementation of 9 mm intrabronchial valves DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe airflow obstruction, severe emphysema, significant hyperinflation, and moderate to severe dyspnea . Eligible patients will have severe emphysema in a target lobe with an intact fissure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Lung Clinic Hemer: collaborator
• Asklepios Kliniken Hamburg GmbH: collaborator
• Otto Wagner Hospital: collaborator

Study Sites (1)

Thoraxklinik, University of Heidelberg

Heidelberg, 69126, Germany

RECRUITING

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix Herth, Prof.Dr.med.

  University Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Herth, Prof.

CONTACT

+49(0)6221/3961201; herth@uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)