Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)

Boston Scientific Corporation1 site in 1 country47 target enrollmentFebruary 2010

ConditionsEmphysema

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Emphysema
Sponsor: Boston Scientific Corporation
Enrollment: 47
Locations: 1
Primary Endpoint: St. George's Respiratory Questionnaire (SGRQ)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

September 2013

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient greater than or equal to 35 years of age
•High resolution CT scan indicates unilateral or bilateral emphysema
•High resolution CT scan indicates homogeneous or heterogeneous emphysema
•Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
•Total Lung Capacity greater than 100% predicted
•Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
•Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
•Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria

•Patient has a change in FEV1 greater than 20% post-bronchodilator
•Patients DLCO less than 20% predicted
•Patient has a history of recurrent clinically significant respiratory infection
•Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
•Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
•Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
•Patient is pregnant or lactating
•Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
•Patient has clinically significant bronchiectasis
•Patient has giant bullae greater than 1/3 lung volume

Outcomes

Primary Outcomes

St. George's Respiratory Questionnaire (SGRQ)

Time Frame: three month Follow-Up Visit

The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.