Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)

Summary

Participation Requirements

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 ...

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).

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