Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-27
Brief Title:
A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists With Varicose Vein and Knee Pain
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
NovoBliss Research Pvt Ltd
Study Overview
Official Title:
Prospective Open-Label Control-group Proof-Of-Science Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists With Varicose Vein and Self-Declared Knee Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Prospective Open-Label Control-group Proof-Of-Science Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain
Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled
Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled
Detailed Description:
Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent
Panelists shall be instructed to visit the facility for the following scheduled visits
Visit 01 Day 01 Screening enrolment evaluations at baseline test product and subject diary distribution followed by evaluations after 1 hour 10 minutes
Visit 02 Day 03 1 day Evaluations at Day 03 1 day
Visit 03 07 2 days 1-week evaluations at Day 07 2 days
Visit 04 282 days Subject diary review followed by end of study evaluations
Panelists shall be instructed to visit the facility for the following scheduled visits
Visit 01 Day 01 Screening enrolment evaluations at baseline test product and subject diary distribution followed by evaluations after 1 hour 10 minutes
Visit 02 Day 03 1 day Evaluations at Day 03 1 day
Visit 03 07 2 days 1-week evaluations at Day 07 2 days
Visit 04 282 days Subject diary review followed by end of study evaluations
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