Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
Study NCT ID:
NCT04733092
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2021-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Prospective Study of the Safety and Efficacy of the Use of a Lipiodol Emulsion for the Embolization of Inflammatory Hypervascularizations Observed in Patients With Joint or Abarticular Knee Pain
Status:
COMPLETED
Status Verified Date:
2023-08
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:
LipioJoint1
Brief Summary:
Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.
Detailed Description:
It is a Phase 1, Single-Arm, Open-label, Multicenter Interventional Prospective Study.
In order to ensure the best possible patient safety, a sequential inclusion of the first 6 patients is planned. Thus, the inclusion of each subsequent patient (patient 2-6) will only be considered after reviewing previously included patient safety data. Safety data after the inclusion of each patient (after a step-back of at least one week), as well as the cumulative review of previously included patient safety data, will be brought to the attention of all investigators involved in this research.
In addition, the following information will be transmitted to the Competent Authority without delay:
* a review of the safety and efficacy of the first 3 patients included with a step back for the last patient of at least one week after the administration of the experimental drug, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred in relation to the expected profit
* a review of the safety and effectiveness of the first 3 patients after the inclusion of the first 6 patients, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred compared to the expected benefit.
The patients will be embolized by the Interventional Radiology Department of the European Hospital Georges Pompidou (HEGP). Embolization will be performed by an experienced radiologist during a conventional hospitalization or a day hospitalization. A clinical follow-up will be carried out at 1 week, 1 month and 3 months after embolization by clinics and patient self-assessment (WOMAC, SF-36).
In order to ensure the best possible patient safety, a sequential inclusion of the first 6 patients is planned. Thus, the inclusion of each subsequent patient (patient 2-6) will only be considered after reviewing previously included patient safety data. Safety data after the inclusion of each patient (after a step-back of at least one week), as well as the cumulative review of previously included patient safety data, will be brought to the attention of all investigators involved in this research.
In addition, the following information will be transmitted to the Competent Authority without delay:
* a review of the safety and efficacy of the first 3 patients included with a step back for the last patient of at least one week after the administration of the experimental drug, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred in relation to the expected profit
* a review of the safety and effectiveness of the first 3 patients after the inclusion of the first 6 patients, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred compared to the expected benefit.
The patients will be embolized by the Interventional Radiology Department of the European Hospital Georges Pompidou (HEGP). Embolization will be performed by an experienced radiologist during a conventional hospitalization or a day hospitalization. A clinical follow-up will be carried out at 1 week, 1 month and 3 months after embolization by clinics and patient self-assessment (WOMAC, SF-36).
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-002206-10 | EUDRACT_NUMBER | None | View |