Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650631
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
The Effectiveness of Heat Treatment on Knee Pain in Patients with Osteoarthritis - an International Multicenter Clinical Investigation
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 8hd
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None