NCT05886608

Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function

Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function: a Post-market Confirmatory Interventional, Single Arm Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Contrad Swiss SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function

Detailed description

The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.

Conditions

• Pain, Acute
• Pain, Chronic
• Knee Injuries
• Knee Osteoarthritis
• Knee Arthritis
• Knee Pain Swelling

Interventions

Type	Name	Description
DEVICE	AI 500™ SINGLE-DOSE GEL	AI500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, intended to provide relief in cases of pain due to tension in muscles and adjacent tissues, to improve movement and function.

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-03-16
• Completion: 2023-03-16
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: Italy