REACH SVS Control Patient Cross-Over Study

Not Applicable

Completed

• Conditions: Emphysema

• Registration Number: NCT02914340
• Lead Sponsor: Olympus Corporation of the Americas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2017-06
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume at 1 second	Three months

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China