CClinicalTrials.gg
CompletedNCT02914340Updated Oct 24, 2018

REACH SVS Control Patient Cross-Over Study

An interventional study of Spiration Valve System in Emphysema, sponsored by Olympus Corporation of the Americas. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Olympus Corporation of the Americas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Emphysema
03

In context

Pulmonary Emphysema

187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.

This study's enrollment of 9 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.

Browse Pulmonary Emphysema studies →

Lead sponsor

Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • DeviceSpiration Valve System
06

What researchers measure

Primary outcomes

  1. Forced expiratory volume at 1 second

    Time frame: Three months

07

Study locations

1 site
  • The First Affiliated Hospital of Guangzhou Medical College
    Guangzhou, Guangdong, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02914340
Lead sponsor
Olympus Corporation of the Americas
Responsible party
Sponsor
First posted
Sep 26, 2016
Start date
Sep 2016
Primary completion
Jun 2017
Completion
Sep 2018
Last update
Oct 24, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion