NCT06440889

A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists with Varicose Vein and Knee Pain.

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

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 (28±2 days): Subject diary review, followed by end of study evaluations.

Conditions

• Varicose Veins with Self-declared Knee Pain

Interventions

Type	Name	Description
DEVICE	Bio-Ray Knee Guard	Wear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours)

Timeline

• Start date: 2024-05-31
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2024-06-04
• Last updated: 2025-03-03

Locations

1 site across 1 country: India