Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497140
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Randomized Sham-controlled Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
LIPIOJOINT-2
Brief Summary:
Knee OsteoArthritis KOA is a common disease associated with pain and impaired function Many patients are not relieved of their symptoms with enough efficacy by conservative treatments Genicular Arteries Embolization GAE is a new minimally invasive endovascular treatment allowing symptoms relief The investigator previously demonstrated the safety of GAE using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a first-in-man single-arm clinical trial called LipioJoint-1 clinicaltrialsgov NCT04733092 EUDRACT 2020-002206-10 This phase 1 study also provided encouraging evidence of GAE efficacy on knee pain and function
The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter prospective randomized sham-controlled clinical trial
The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter prospective randomized sham-controlled clinical trial
Detailed Description:
Patients will be screened during current practice consultation in each recruiting center Screening Visit When a patient will meet the eligibility criteria he will be informed about the protocol
The Interventional Radiologist will further explain the protocol to the patient and check inclusionnon-inclusion criteria during baseline visit The date of signature of the informed consent by the patient will be considered as the date of inclusion GAE embolization will be scheduled within the next few days
Randomization will occur during the embolization visit before patient is taken to the operating room Randomization in a 21 ratio of GAE using emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score 2-3 versus 4 All target arteries will be injected with an ethiodized oil-based emulsion GAE group Patient will be kept blind to the actual treatment using headphones or virtual headset
Follow-up visits will be scheduled 1 3 6 and 12 months after randomization Patient will be informed about his randomisation group GAE or sham after the completion of questionnaires VAS pain WOMAC EQ-5D HAD at the 3-month visit and will be allowed to choose further medical clinical management of his target KOA
The Interventional Radiologist will further explain the protocol to the patient and check inclusionnon-inclusion criteria during baseline visit The date of signature of the informed consent by the patient will be considered as the date of inclusion GAE embolization will be scheduled within the next few days
Randomization will occur during the embolization visit before patient is taken to the operating room Randomization in a 21 ratio of GAE using emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score 2-3 versus 4 All target arteries will be injected with an ethiodized oil-based emulsion GAE group Patient will be kept blind to the actual treatment using headphones or virtual headset
Follow-up visits will be scheduled 1 3 6 and 12 months after randomization Patient will be informed about his randomisation group GAE or sham after the completion of questionnaires VAS pain WOMAC EQ-5D HAD at the 3-month visit and will be allowed to choose further medical clinical management of his target KOA
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC-22-0033 | OTHER_GRANT | None | None |
| 2023-508844-24-00 | CTIS | None | None |