Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132048
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-31
Brief Title:
A Usability Validation of the MuCopilot Mobile Application a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Sponsor:
Ad scientiam
Organization:
Ad scientiam
Study Overview
Official Title:
A Usability Validation of the MuCopilot Mobile Application a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MuControl-Sum
Brief Summary:
The study aims to assess the usability and safety of use of MuCopilot a smartphone application that measures objective data on lung function global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis CF These data are collected during unsupervised digital tests performed in the patients home environment between consultations
The primary objective is to validate the usability and safety of use in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk
The study will include 17 CF patients and will be conducted in France They will participate in 1 inclusion visit and 1 visit in-clinic 1h30
Patients will be able to download the free MuCopilot mobile application During the visit patients will complete 3 digital tests in order to monitor CF functions cough dyspnea walking and 1 symptom questionnaire
The primary objective is to validate the usability and safety of use in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk
The study will include 17 CF patients and will be conducted in France They will participate in 1 inclusion visit and 1 visit in-clinic 1h30
Patients will be able to download the free MuCopilot mobile application During the visit patients will complete 3 digital tests in order to monitor CF functions cough dyspnea walking and 1 symptom questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None