REACH SVS Control Patient Cross-Over Study

Emphysema Clinical Trial

Official title:

REACH (Research to Assess SVS Safety and Effectiveness for the Treatment of Severe EmphysemA in China) SVS Control Patient Cross-Over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914340
• Other study ID #: CPR-04524
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Spiration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Spiration Valve System

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Spiration, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume at 1 second		Three months