NCT01334307CompletedPhase 1
Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
Boston Scientific Corporation3 sites in 1 country47 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 47
- Locations
- 3
- Primary Endpoint
- St. George's Respiratory Questionnaire (SGRQ)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patient has had previous LVR surgery, lung transplant or lobectomy
- •Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- •Patient is taking greater than 20 mg prednisone (or similar steroid) daily
- •Patient is on Plavix or has not been weaned off prior to procedure
- •Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Arms & Interventions
Lung Volume Reduction Coil (LVRC)
Experimental
Lung Volume Reduction Coil (LVRC)
Intervention: Lung Volume Reduction Coil (LVRC) (PneumRx) (Device)
Control
Placebo Comparator
Standard of Care
Intervention: Control (Device)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
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