Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) (LipioJoint1)
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| ClinicalTrials.gov Identifier: NCT04733092 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2021
Last Update Posted : May 13, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Drug: Lipiodol | Phase 1 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 22 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 3, 2021 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | June 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Embolization
Embolization of the inflammatory hypervascularization with a lipiodol emulsion
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Drug: Lipiodol
Lipiodol in emulsion with contrast agent
Other Name: Optiray |
- Serious Adverse Events (SAE) [ Time Frame: 1 month ]Number of SAE related to Embolization
- Immediate Technical success [ Time Frame: Intraoperative ]Success of catheterization and embolization of target hypervascularization
- Pain improvement 1 week after embolization [ Time Frame: 1 week ]Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)
- Pain improvement 1 month after embolization [ Time Frame: 1 month ]Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)
- Pain improvement 3 month after embolization [ Time Frame: 3 months ]Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)
- Articular impotence improvement 1 week after embolization [ Time Frame: 1 week ]Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline
- Articular impotence improvement 1 month after embolization [ Time Frame: 1 month ]Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline
- Articular impotence improvement 3 month after embolization [ Time Frame: 3 months ]Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline
- Quality of life improvement 3 month after embolization [ Time Frame: 3 months ]Short Form Health Survey (SF-36) score comparison to baseline SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
- Pain medication improvement 1 week after embolization [ Time Frame: 1 week ]Dose of analgesic medication compared to baseline (mg/24h)
- Pain medication improvement 1 month after embolization [ Time Frame: 1 month ]Dose of analgesic medication compared to baseline (mg/24h)
- Pain medication improvement 3 month after embolization [ Time Frame: 3 months ]Dose of analgesic medication compared to baseline (mg/24h)
- Patient's satisfaction [ Time Frame: 3 months ]Patient's satisfaction questionnaire : qualitative questionnaire with 5 ordered modalities (0 = no to 4 = yes)
- Adverse Events (AE) [ Time Frame: 3 months ]Number of AE related to embolization
- Serious Adverse Events (SAE) [ Time Frame: 3 months ]Number of SAE related to embolization
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| Ages Eligible for Study: | 35 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a knee osteoarthritis according to the American College of Rheumatology (ACR) classification and a score ≥ 2 according to the classification of Kellgren and Lawrence
- Patient not eligible for surgery (or refusing surgery)
- Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3 months
- Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen, and/or failure or intolerance or patient refusing strong opioids medication (morphine, codeine)
- Failure or patient refusal of corticosteroid infiltration
- Patient who has signed an informed consent
Exclusion Criteria:
- Patient who is unable or unable to comply with the follow-up schedule
- Infiltration of target joint less than three months old
- Treated hyperthyroidism
- Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint
- Known arterial disease of the lower limbs stage ≥ 2 according to the classification of Leriche and Fontaine
- Known severe allergy to Lipiodol® and/or iodized contrast product
- Known severe kidney failure (creatinine clearance < 30 ml/min)
- Pregnant or breastfeeding woman
- Patient not affiliated with a French Medicare
- Patient benefiting from legal protection
- Participation in another interventional research
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04733092
| Contact: Marc MD Sapoval, PhD | 01 56 09 37 40 | marc.sapoval2@aphp.fr | |
| Contact: Cléo Bourgeois | 01 56 09 56 38 | cleo.bourgeois@aphp.fr |
| France | |
| Hôpital européen Georges Pompidou | Recruiting |
| Paris, France, 75015 | |
| Contact: Marc MD Sapoval, PhD 01 56 09 37 40 marc.sapoval2@aphp.fr | |
| Contact: Carole Dean 01 56 09 37 19 carole.dean@aphp.fr | |
| Principal Investigator: | Marc MD Sapoval, PhD | AP-HP, Hôpital Européen Georges Pompidou, Paris |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT04733092 |
| Other Study ID Numbers: |
APHP190891 2020-002206-10 ( EudraCT Number ) |
| First Posted: | February 1, 2021 Key Record Dates |
| Last Update Posted: | May 13, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared. |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Time Frame: | 2 years after the last publication |
| Access Criteria: | Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR). Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contracting |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lipiodol musculoskeletal disorders embolization |
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Ethiodized Oil Antineoplastic Agents |