- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914340
REACH SVS Control Patient Cross-Over Study
October 22, 2018 updated by: Spiration, Inc.
REACH (Research to Assess SVS Safety and Effectiveness for the Treatment of Severe EmphysemA in China) SVS Control Patient Cross-Over Study
This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients.
The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangzhou Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient was enrolled in the REACH SVS Study control group and has completed their participation in the Study including the 12 month follow-up visit.
- Patient has received standard-of-care medical management and it has been stable for 6 weeks.
- 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 is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study.
- Patient has demonstrated unwillingness or inability to complete baseline data collection procedures.
- 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 prior 3 months.
- Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period
- Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
The treatment algorithm is complete occlusion of one lobe of the lung by using valves to occlude all segments of the lobe.
The lobe will be selected based on imaging with high resolution computed tomography (HRCT).
The lobe to be treated will have severe heterogeneous emphysema based on visual exam.
The selected lobe will also have an intact fissure separation with the ipsilateral lobe.
An intact fissure will be estimated visually to be ≥ 90% complete after viewing the HRCT in 3 dimensions.
If more than one lobe meets criteria, the investigator will determine a primary lobe to treat based on fissure completeness, heterogeneity, disease severity, and the anatomy of the airways that will be treated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume at 1 second
Time Frame: Three months
|
Three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimate)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
October 24, 2018
Last Update Submitted That Met QC Criteria
October 22, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR-04524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
-
Aeris TherapeuticsCompleted
-
University Medical Center GroningenRecruitingEmphysema or COPDNetherlands
-
University Medical Center GroningenCompletedEmphysema or COPDNetherlands
-
Rabin Medical CenterUnknownPatients With Advanced Homogeneous EmphysemaIsrael
Clinical Trials on Spiration Valve System
-
Ohio State UniversitySpiration, Inc.WithdrawnManagement of BPF (Bronchopleural Fistulae)United States
-
Olympus Corporation of the AmericasTerminated
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Olympus Corporation of the AmericasRecruiting
-
Spiration, Inc.Tigermed Consulting Co., Ltd; Olympus CorporationCompletedPulmonary Disease, Chronic Obstructive | EmpyhsemaChina
-
Royal Brompton & Harefield NHS Foundation TrustCompletedHeterogeneous EmphysemaUnited Kingdom
-
Spiration, Inc.CompletedEmphysemaUnited States, Canada
-
Heidelberg UniversityTerminatedHereditary Emphysema (Alpha 1-antitrypsin Deficiency)Germany
-
Heidelberg UniversitySpiration, Inc.UnknownPulmonary EmphysemaGermany
-
Heidelberg UniversityCompleted