Emphysema Clinical Trial
Official title:
Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
Verified date | July 2021 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | September 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | PneumRx, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | St. George's Respiratory Questionnaire (SGRQ) | 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. | three month Follow-Up Visit |
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