Status:
TERMINATED
Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
PneumRx, Inc.
Conditions:
COPD Symptoms After Coil Procedure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management program manufactured and o...
Detailed Description
COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application (an "app") with facilitation of rapid personalized clinical recommendations made by the participant's health...
Eligibility Criteria
Inclusion
- Participant has read, understood, and signed a CLN0020 informed consent form prior to enrollment.
- Participant is appropriate for Coil treatment per the Conformité Européene (European Conformity \[CE\])-Mark Approved RePneu Instructions for Use (IFU).
- Participant has been enrolled in and scheduled for treatment(s) with the PneumRx Endobronchial Coil procedure in the CLN0014 study.
- Participant's PneumRx Endobronchial Coil procedure is scheduled to occur no fewer than 14 days from enrollment, providing enough time to establish a baseline of their daily symptoms. Ten days minimum of baseline data are required, which is defined as the Run-in period going forward.
- Participant is willing and able to use a smart phone.
Exclusion
- Participant has undergone a Coil procedure.
- Participant has had an acute exacerbation of COPD that required hospitalization or emergency room visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to CLN0020 enrollment.
- Participant has a COPD exacerbation or respiratory illness during the Run-in period that in the judgment of the investigator requires medical intervention (for example, treatment with systemic steroids and/or antibiotics and/or hospitalization).
- Participant is suffering from terminal illness expected to adversely affect survival in the next 12 months.
- Participant has a history of non-compliance with medical therapies.
Key Trial Info
Start Date :
February 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03267992
Start Date
February 10 2017
End Date
October 20 2018
Last Update
July 16 2021
Active Locations (2)
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1
Hôpitaux Universitaires de Genève (HUG) Service
Geneva, Switzerland, 1211
2
UniversitätsSpital
Zurich, Switzerland, 8091