REACH SVS Control Patient Cross-Over Study

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

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Spiration Valve System

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical College

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

Device: Spiration Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Forced expiratory volume at 1 second	Three months

Collaborators and Investigators

• Sponsor: Spiration, Inc.

Study record dates

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: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CPR-04524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED