Status:
COMPLETED
MN4000 for Treatment of CF and MND Patients in the Home Setting
Lead Sponsor:
Hill-Rom
Conditions:
Cystic Fibrosis
Motor Neuron Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000. This pilot study e...
Detailed Description
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000. This pilot study e...
Eligibility Criteria
Inclusion
- Documented diagnosis of CF or MND
- Age ≥ 18 years
- Signed informed consent
Exclusion
- Requirement for continuous mechanical ventilation
- Anticipated requirement for hospitalization within the next three months
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
- Inability to perform MN4000 therapy as directed
- Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
Key Trial Info
Start Date :
March 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03797677
Start Date
March 9 2017
End Date
November 30 2017
Last Update
August 7 2024
Active Locations (1)
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1
Northwestern
Chicago, Illinois, United States, 60208