Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395025
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2024-04-29
Brief Title:
Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group
Sponsor:
Millet Innovation
Organization:
Millet Innovation
Study Overview
Official Title:
Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
The primary goal of this study is to assess in vivo the efficacy of the insoles in improving venous return in subjects affected by this problem after 14 days of the initial measurements by self-assessment filling-in questions regarding Quality of Life in comparison with a control group
The secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device after 14 days of using the medical device by selfassessment filling-in subjective evaluation questions
The secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device after 14 days of using the medical device by selfassessment filling-in subjective evaluation questions
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