Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06087705
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Sponsor:
LCA Pharmaceutical
Organization:
Study Overview
Official Title:
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YNOVIUM
Brief Summary:
Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.
Detailed Description:
Inclusion period: 6 months
Follow-up period:
* 6-month follow-up, after intra-articular injection with extension
* 1 single syringe of SYNOVIUM HCS (3 mL),
* Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
* Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
* Duration of the study: Overall time estimated at 18 months
* In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.
Follow-up period:
* 6-month follow-up, after intra-articular injection with extension
* 1 single syringe of SYNOVIUM HCS (3 mL),
* Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
* Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
* Duration of the study: Overall time estimated at 18 months
* In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: