Skip to main content
OpenTrials
Completed

NCT Number: NCT02914340

REACH 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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spiration Valve System

Device

Primary outcomes

  1. Forced expiratory volume at 1 second

    Time frame: Three months

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2016
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.