Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06040112
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Sponsor:
Hyungsuk Kim
Organization:
Study Overview
Official Title:
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
None
Brief Summary:
Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.
Detailed Description:
Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure.
Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.
Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."
Clinical outcomes will be assessed with functional scores on 6 months after injection.
Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.
Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."
Clinical outcomes will be assessed with functional scores on 6 months after injection.
Study Oversight
Has Oversight DMC:
None
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?: