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RECRUITING
NCT06650631
NA

The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation

Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

View on ClinicalTrials.gov

Summary

This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).

Official title: The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation

Key Details

Gender

All

Age Range

19 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-10-21

Completion Date

2025-08-29

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DEVICE

Knee Heatwraps

To treat the painful knee joint in patients with osteoarthritis without acute flares or inflammation. The investigational device will be used in accordance with the Instructions for Use.

Locations (1)

Ars Medica Clinic

Gravesano, Switzerland, Switzerland