OsteoarthritisPhase 1/2EMBARDINCT06611007
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment
A Phase 1/2 study testing embolization therapy in people with Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- embolization therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2025to 15 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 40 years.
- Osteoarthritis of the hand according to American College of Rheumatology criteria 1990
- Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥ 2.
- Symptomatic osteoarthritis within the last 3 months.
- Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painful hand).
- Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
- Patient affiliated to french social security or a similar health assurance.
Who cannot join
- History of allergy to iodinated contrast media, LipiodolⓇ or poppies.
- Vasomotor disorders (Raynaud\'s syndrome, scleroderma, acrocyanosis).
- Stenosis (\>50%) or known atheromatous arterial occlusion of the upper limbs.
- Obliterative arterial disease of the lower limbs at the critical ischaemia stage.
- Severe to end-stage chronic renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m2), dialysis or renal transplant.
- Arteritis such as thromboangiitis obliterans disease or other diseases
Show all 13Show fewer
- Previous thrombosis/dissection of the radial artery.
- Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.).
- Known hyperthyroidism or large multinodular goiter.
- Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completely resolved within 3 months of the start of the lesion) requiring embolisation.
- Pregnant or breast-feeding.
- Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code and/or who do not speak French.
- Patients in a period of exclusion or in the course of another interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emeric Gremen, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes - Sud site
Échirolles, 38130
Xavier ROMAND, MD, PHD, 0476767223, xromand@chu-grenoble.fr
Emeric GREMEN, MD, PHD, 0476765829, egremen@chu-grenoble.fr
About this study
Official title: Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function.
The main questions it aims to answer are:
Read more
- What are the side effects and complications associated with the Lipiodol® arterial embolization procedure?
- Does arterial embolization reduce pain intensity and improve hand function?
Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will:
- Undergo arterial embolization with Lipiodol®
- Participate in regular follow-ups to monitor pain relief, hand function, and any side effects
- Have imaging studies to assess changes in joint vascularisation and damage
- Conditions
- Osteoarthritis
- Being tested
- embolization therapy
- Keywords
- Therapeutic embolization, Safety, Hand osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization therapyDrug
Hand arterial embolization with Lipiodol in emulsion with iodinated contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Arterial embolization of the hand with Lipiodol | Experimental | The radial artery will be embolized with Lipiodol emulsified 3:1 with iodinated contrast medium (Optiray 300 mg/ml). The most painful hand according to VAS pain will be treated. Receives: Drug: embolization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
The primary endpoint is the number and frequency of embolisation-related adverse events throughout the study period (6 months). Each adverse event will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to grade 5 (fatal).
Measured: From embolization to 6 months after embolization
Secondary outcomes (34)
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Measured: baseline and month 1
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 3. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Measured: Baseline and Month 3
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6
Percentage of patients with at least a 50% improvement in pain on the pain Analog Visual Scale score (0-100) of the treated hand compared to baseline, at month 1. VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The VAS is rated from 0 to 100 (no pain to extremely severe pain).
Measured: Baseline and Month 6
Change From Baseline in Swollen Joints Counts at Month 1
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 1
Change From Baseline in Swollen Joints Counts at Month 3
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 3
Change From Baseline in Swollen Joints Counts at Month 6
Swollen joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 6
Change From Baseline in Tender Joints Counts at Month 1
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 1
Change From Baseline in Tender Joints Counts at Month 3
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 3
Change From Baseline in Tender Joints Counts at Month 6
Tender joints of hand are indentified by clinical examination. Following joints are assessed : wrists, trapeziometacarpal joints, first to five metacarpophalangeal joints, first to five proximal interphalangeal joints, second to five distal interphalangeal joints
Measured: Baseline and Month 6
Change From Baseline in Cochin Hand Function Index score at Month 1
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Measured: From Baseline and Month 1
Change From Baseline in Cochin Hand Function Index score at Month 3
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Measured: From Baseline and Month 3
Change From Baseline in Cochin Hand Function Index score at Month 6
Cochin Hand Function Index Score is a functional disability scale for hand comprising 18 questions on daily activities. This question is completed by the patient. Final score is obtained by adding the score of each question rated on a Likert scale from 0 (done without difficulty) to 5 (impossible to do).
Measured: From Baseline and Month 6
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 1
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Measured: From Baseline and Month 1
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 3
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Measured: From Baseline and Month 3
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 6
The Functional Index for Hand Osteoarthritis (FIHOA) assesses hand osteoarthrits-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).
Measured: From Baseline and Month 6
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 1
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Measured: From Baseline and Month 1
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 3
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Measured: From Baseline and Month 3
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 6
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) is a shortened version of the DASH questionnaire, designed to evaluate upper limb function and symptoms. It consists of 11 questions that measure physical function and symptoms related to daily activities, work, and leisure. Each item is scored on a 5-point scale, with higher scores indicating greater disability. The final score is calculated in accordance with the following formula: =((sum of n responses/n)-1)x25, where n represents the number of completed responses.
Measured: From Baseline and Month 6
Change from Baseline in Hand grip strength at Month 1
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Measured: Baseline and Month 1
Change from Baseline in Hand grip strength at Month 3
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Measured: Baseline and Month 3
Change from Baseline in Hand grip strength at Month 6
Grip strength of the hand is assessed using a Grip Strength Hand Dynamometer. The result is expressed in kilograms.
Measured: Baseline and Month 6
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 1
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 1
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 3
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 3
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 6
Doppler vascularisation was assessed using a semi-quantitative score (0-3, 0: no vascularisation, 3: high vascularisation) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 6
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 1
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 1
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 3
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 3
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 6
Synovitis was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no synovitis, 3: significant synovitis) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 6
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 1
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 1
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 3
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 3
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 6
Joint effusion was assessed using B-mode ultrasound and a semi-quantitative score (0-3, 0: no joint effusion, 3: high joint effusion) in acccordance with OMERACT guidelines.
Measured: Baseline and Month 6
Change from 6 months prior to inclusion in use of pain medication over the 6 months of study
Pain medication will be described using analgesic level.
Measured: From 6 months before inclusion to Month 6
Change in the intensity of neovascularisation in the hand joints, as assessed by arteriography, from before embolisation to immediately after embolisation
A semi-quantitative assessment of neovascularisation (weak/moderate/important) before and after embolisation of the treated hand by analysing vascuralisation throw angiography is performed The following joints are evaluated : Trapezium-metacarpal joint, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, distal interphalangeal (DIP) joints 2-5.
Measured: Before and Immediately after embolisation
Change From Baseline in Ghent University Scoring System (GUSS) at Month 6
The Ghent University Scoring System (GUSS) is a radiographic scoring method specifically developed to evaluate joint damage in hand osteoarthritis. It focuses on assessing both structural damage and remodeling features visible on hand X-rays. Erosive progression and signs of repair or remodelling are scored by indicating the proportion of normal subchondral bone, subchondral plate and joint space on an 11-point rating scale (range 0-100 with 10 unit increases). A lower score indicates greater damage or remodeling. The total score is the sum of these 3 scores for the joint under consideration.
Measured: Baseline and Month 6
Change in hand cutaneous microcirculation assessed by Laser Speckle Contrast Imaging (LSCI) before and during two hours post embolization
A PeriCam PSI device (Perimed, Sweden) will be used to assess skin perfusion in both hands. The image size will be set at 30 x 20 centimetres and the acquisition speed at one image per second. The wavelength chosen will be 785 nm and the laser head will be positioned between 15 and 20 centimetres above the hands (with a resolution of ~ 6.9 pixels/ cm2). Cutaneous blood flow in the areas of interest will be expressed as PU (perfusion unit) and/or CVC (cutaneous vascular conductance). The area of interest will be the whole hand and the area around each hand joint.
Measured: Before embolisation and 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post embolisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start30 Jan 2025
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Romand, MD, PhD, Principal investigator, CHU Grenoble Alpes, site Sud, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611007
- Sponsor's protocol ID
- 38RC23.0227
- Other IDs
- 2024-513361-40-00
- Acronym
- EMBARDI
- Status last verified
- May 2026
- First submitted
- 20 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual data and other informations as study protocole, informed consent form, clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
- ClinicalTrials.gov ID
- NCT06611007
- Acronym / sponsor ID
- EMBARDI / 38RC23.0227
- Conditions
- Osteoarthritis
- Keywords
- Therapeutic embolization, Safety, Hand osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function.
The main questions it aims to answer are:
- What are the side effects and complications associated with the Lipiodol® arterial embolization procedure?
- Does arterial embolization reduce pain intensity and improve hand function?
Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will:
- Undergo arterial embolization with Lipiodol®
- Participate in regular follow-ups to monitor pain relief, hand function, and any side effects
- Have imaging studies to assess changes in joint vascularisation and damage
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial embolization of the hand with Lipiodol | Experimental | Drug: embolization therapyThe radial artery will be embolized with Lipiodol emulsified 3:1 with iodinated contrast medium (Optiray 300 mg/ml). The most painful hand according to VAS pain will be treated. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥ 40 years.
- Osteoarthritis of the hand according to American College of Rheumatology criteria 1990
- Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥ 2.
- Symptomatic osteoarthritis within the last 3 months.
- Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painful hand).
Key exclusion criteria (13 listed)
- History of allergy to iodinated contrast media, LipiodolⓇ or poppies.
- Vasomotor disorders (Raynaud\'s syndrome, scleroderma, acrocyanosis).
- Stenosis (\>50%) or known atheromatous arterial occlusion of the upper limbs.
- Obliterative arterial disease of the lower limbs at the critical ischaemia stage.
- Severe to end-stage chronic renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m2), dialysis or renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolization therapyHand arterial embolization with Lipiodol in emulsion with iodinated contrast agent | Drug | Arterial embolization of the hand with Lipiodol |
Primary outcome
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
Time frame: From embolization to 6 months after embolization
The primary endpoint is the number and frequency of embolisation-related adverse events throughout the study period (6 months). Each adverse event will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to grade 5 (fatal).
34 secondary outcomes
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1
Time frame: baseline and month 1
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3
Time frame: Baseline and Month 3
Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6
Time frame: Baseline and Month 6
Change From Baseline in Swollen Joints Counts at Month 1
Time frame: Baseline and Month 1
Change From Baseline in Swollen Joints Counts at Month 3
Time frame: Baseline and Month 3
Change From Baseline in Swollen Joints Counts at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Tender Joints Counts at Month 1
Time frame: Baseline and Month 1
Change From Baseline in Tender Joints Counts at Month 3
Time frame: Baseline and Month 3
Change From Baseline in Tender Joints Counts at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Cochin Hand Function Index score at Month 1
Time frame: From Baseline and Month 1
Change From Baseline in Cochin Hand Function Index score at Month 3
Time frame: From Baseline and Month 3
Change From Baseline in Cochin Hand Function Index score at Month 6
Time frame: From Baseline and Month 6
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 1
Time frame: From Baseline and Month 1
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 3
Time frame: From Baseline and Month 3
Change From Baseline in Functional Index for Hand Osteoarthritis at Month 6
Time frame: From Baseline and Month 6
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 1
Time frame: From Baseline and Month 1
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 3
Time frame: From Baseline and Month 3
Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 6
Time frame: From Baseline and Month 6
Change from Baseline in Hand grip strength at Month 1
Time frame: Baseline and Month 1
Change from Baseline in Hand grip strength at Month 3
Time frame: Baseline and Month 3
Change from Baseline in Hand grip strength at Month 6
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 1
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 3
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 6
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 1
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 3
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 6
Time frame: Baseline and Month 6
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 1
Time frame: Baseline and Month 1
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 3
Time frame: Baseline and Month 3
Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 6
Time frame: Baseline and Month 6
Change from 6 months prior to inclusion in use of pain medication over the 6 months of study
Time frame: From 6 months before inclusion to Month 6
Change in the intensity of neovascularisation in the hand joints, as assessed by arteriography, from before embolisation to immediately after embolisation
Time frame: Before and Immediately after embolisation
Change From Baseline in Ghent University Scoring System (GUSS) at Month 6
Time frame: Baseline and Month 6
Change in hand cutaneous microcirculation assessed by Laser Speckle Contrast Imaging (LSCI) before and during two hours post embolization
Time frame: Before embolisation and 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post embolisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Access to anonymized individual data and other informations as study protocole, informed consent form, clinical study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emeric Gremen, MD contact
Xavier Romand, MD, PhD principal investigator
CHU Grenoble Alpes, site Sud, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing embolization therapy in people with Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Romand, MD, PhD (0476767223 ext. +33, xromand@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE (time frame: From embolization to 6 months after embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.