Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562205
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
PAP Systems External Clinical Studies ECS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
External Evaluation of PAP Systems Comparison of PAP Flow Generators Machines Mask Systems and Tubing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems
Detailed Description:
This is an open label prospective randomized cross over or single arm study for ongoing product development of new accessories for PAP devices This generic protocol provides a framework methodology for how these ongoing studies will be conducted This protocol then is used in a number of smaller sub-studies phases each of which will have their own sub-protocol outlining the exact specifics of the study
The studies could be run face-to-face or remotely
Participants who met the inclusionexclusion criteria will be contacted Recruitment will be done via emails Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit
Visit 1 Participants will provide written informed consent Participants will be shown the PAP systems and trial them for fit and comfort Participants may be asked initial questions on their first thoughts on the PAP systems If the participant and assessor are happy to proceed the participants will use the loan PAP system for trial
Visit 2 After trialing the PAP systems participants will be asked to complete a questionnaire regarding the appeal comfort and usability of the PAP systems Depending on sub-study protocol participants will then take the second PAP system home to test
Visit 3 The participant will return the loan PAP system to the assessor The participants questionnaire responses will be reviewed This concludes the participation in the study
The studies could be run face-to-face or remotely
Participants who met the inclusionexclusion criteria will be contacted Recruitment will be done via emails Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit
Visit 1 Participants will provide written informed consent Participants will be shown the PAP systems and trial them for fit and comfort Participants may be asked initial questions on their first thoughts on the PAP systems If the participant and assessor are happy to proceed the participants will use the loan PAP system for trial
Visit 2 After trialing the PAP systems participants will be asked to complete a questionnaire regarding the appeal comfort and usability of the PAP systems Depending on sub-study protocol participants will then take the second PAP system home to test
Visit 3 The participant will return the loan PAP system to the assessor The participants questionnaire responses will be reviewed This concludes the participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None