Back to resultsREACH SVS Control Patient Cross-Over Study
Primary Purpose
Emphysema
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spiration Valve System
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Forced expiratory volume at 1 second
Secondary Outcome Measures
Full Information
NCT ID
NCT02914340
First Posted
September 22, 2016
Last Updated
October 22, 2018
Sponsor
Olympus Corporation of the Americas
1. Study Identification
Unique Protocol Identification Number
NCT02914340
Brief Title
REACH SVS Control Patient Cross-Over Study
Official Title
REACH (Research to Assess SVS Safety and Effectiveness for the Treatment of Severe EmphysemA in China) SVS Control Patient Cross-Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation of the Americas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spiration Valve System
Primary Outcome Measure Information:
Title
Forced expiratory volume at 1 second
Time Frame
Three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
REACH SVS Control Patient Cross-Over Study
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