Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654739
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
RCT on the Performance and Safety of LightForce Therapy Lasers on Knee Osteoarthritis Pain Reduction SPARK
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Sham Controlled Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy PBMT With LightForce Therapy Lasers on Knee Osteoarthritis Pain Reduction
Status:
NOT_YET_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:
SPARK
Brief Summary:
DJO UK Ltd ENOVIS is conducting this study to assess the effectiveness of LightForce Therapy Lasers on pain reduction in subjects with unilateral or bilateral knee osteoarthritis like you In detail this study will assess superiority of LightForce Therapy Lasers combined with standard of care represented by physiotherapyexercise program compared to sham laser combined with standard of care physiotherapyexercise program on pain reduction in subjects with knee osteoarthritis In addition this study allows to collect post market clinical data on the safety and performance of LightForce Therapy Lasers when used following the normal clinical practice in accordance with its approved and CE marked intended use
Detailed Description:
This clinical investigation is a post-market International multi center prospective randomized sham controlled single blind study to assess the effectiveness of LightForce Therapy Lasers and to collect PMCF data on the safety and performance of LightForce Therapy Lasers when used in accordance with its approved labeling to comply with Medical Device Regulation EU 2017745 MDR Article 61 and Part B of Annex XI
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