Status:
COMPLETED
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
Lead Sponsor:
Nuvaira, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be eval...
Eligibility Criteria
Inclusion
- FEV1 30% to 60%
- FEV1/FVC \<70%
- Prior smoker (at least 10 pack years)
- Quit smoking for at least 6 months
Exclusion
- Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
- Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
- Pulmonary nodule requiring surgery
- Presence of implantable electronic devices
- Active respiratory infection within recent weeks
- COPD exacerbation within recent weeks
- Recent Myocardial infarction (MI)
- Recent and unstable or life threatening arrhythmia
- Malignancy treated with radiation or chemotherapy within the last 2 years
- Presence or clinical diagnosis of other respiratory diseases other than COPD
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01483534
Start Date
October 1 2011
End Date
November 1 2015
Last Update
September 23 2016
Active Locations (3)
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1
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700
2
Panorama Medi-Clinic
Panorama, Cape Town, South Africa
3
Stellenbosch University
Capetown, South Africa, 7505