Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 3:24 PM
Study NCT ID:
NCT07052851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-07
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Sponsor:
Lipo-Sphere
Organization:
Study Overview
Official Title:
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Detailed Description:
The study aims to evaluate the performance of a single intra-articular injection of CCoat in patients with mild to moderate knee osteoarthritis over 26 weeks. Intra-articular injections are widely used for their localized efficacy and reduced systemic toxicity compared to oral treatments. Current treatments, including corticosteroids and hyaluronic acid, have limitations such as short-term effects and potential cartilage damage \[1\],\[2\],\[3\],\[4\]. Platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) offer promise but require further validation \[5\],\[6\],\[7\]. CCoat, a liposomal boundary lubricant, provides a novel approach by coating cartilage surfaces to reduce wear, offering mechanical protection without altering synovial fluid properties.
CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from mild to moderate knee osteoarthritis (OA), developed by Liposphere LTD. CCoat is a liposomal boundary lubricant that coats the cartilage surface and temporarily protects it from further damage and degradation.
The performance and safety of CCoat device over 26 weeks is being evaluated in another multi-center, prospective, placebo controlled, randomized, double- blinded clinical study in 150 patients with mild to moderate OA of the knee (per study protocol # CLD0000616). As this study is ongoing, there is no currently available data related to the performance of the device. With regards to the CCoat's safety, in the interim analysis no safety concerns were raised.
This clinical investigation aims to further confirm the performance of CCoat when used as intended for the treatment of mild to moderate knee osteoarthritis (OA) in a larger patient population group, in comparison to a marketed hyaluronic acid product. This study is critical to further confirm the benefit-risk profile of the CCoat device as a valid therapeutic option for knee OA treatment, which remains a significant unmet medical need.
CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from mild to moderate knee osteoarthritis (OA), developed by Liposphere LTD. CCoat is a liposomal boundary lubricant that coats the cartilage surface and temporarily protects it from further damage and degradation.
The performance and safety of CCoat device over 26 weeks is being evaluated in another multi-center, prospective, placebo controlled, randomized, double- blinded clinical study in 150 patients with mild to moderate OA of the knee (per study protocol # CLD0000616). As this study is ongoing, there is no currently available data related to the performance of the device. With regards to the CCoat's safety, in the interim analysis no safety concerns were raised.
This clinical investigation aims to further confirm the performance of CCoat when used as intended for the treatment of mild to moderate knee osteoarthritis (OA) in a larger patient population group, in comparison to a marketed hyaluronic acid product. This study is critical to further confirm the benefit-risk profile of the CCoat device as a valid therapeutic option for knee OA treatment, which remains a significant unmet medical need.
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?: