Knee OsteoarthritisPhase 3LIPIOJOINT-2NCT06497140
Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
A Phase 3 study testing Ethiodized Oil-based emulsion in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ethiodized Oil-based emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Sep 2024to 1 Oct 2028
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
- Radiographic Kellgren and Lawrence score ≥ 2 (6)
- VAS pain score ≥ 40 mm (scale 0-100 mm)
- Previous intra-articular injection in the target knee
- Patient not eligible to knee surgery
- For woman of childbearing potential: negative bêta-HCG before randomization
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- Social security affiliation
- Signed informed consent
- Good understanding of the French language
Who cannot join
- Intra-articular injection of any product in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Any inflammatory joint disease other than osteoarthritis
- Any contra-indication to puncture of the ipsilateral femoral artery
- Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- Ipsilateral symptomatic hip OA
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- Treated hyperthyroidism
- Known severe allergy to Lipiodol® and/or iodine contrast medium
- Known moderate to severe kidney failure (creatinine clearance < 30 45 ml/min)
- Known right-to-left cardiac shunt or intra-tumoral vascular shunt
- Asthma attack in the 8 days before randomization
- Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
- Symptomatic atheromatous lesion in the ipsilateral limb
- Patient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)
- Vulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)
- Patient under exclusion period in another trial
- Patient on AME (state medical aid)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Saint Antoine - APHP
Paris, 75012
Jérémie SELLAM, MD, 0149282520, jeremie.sellam@aphp.fr
Jérémie SELLAM, MD
- Recruiting
Hôpital Cochin - APHP
Paris, 75014
François RANNOU, MD, 0158412587, francois.rannou@aphp.fr
François RANNOU, MD
- Recruiting
Hôpital européen Georges Pomidou - APHP
Paris, 75015
Marc SAPOVAL, MD, 0156093740, marc.sapoval2@aphp.fr
Carole DEAN, PhD, 0156093719, carole.dean@aphp.fr
About this study
Official title: A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
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 (clinicaltrials.gov: 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.
Read the 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 inclusion/non-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 2:1 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ethiodized Oil-based emulsion, Sham-operation
- Keywords
- Embolization, Pain, Randomized sham-controlled trial
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethiodized Oil-based emulsionDrug
Embolization of genicular arteries
Sham-operationProcedure or surgery
Mimicked catheterization and embolization of genicular arteries
| Study group | Role | What they receive |
|---|---|---|
| Embolization group | Experimental | Genicular arteries embolization of the target knee will be performed using an ethiodized oil-based emulsion (3:1 mix of ethiodized oil and contrast agent ioversol 300 mgI/ml); 86 patients will be allocated to embolization group (2:1 randomization). Receives: Drug: Ethiodized Oil-based emulsion |
| Sham group | Sham comparator | All the gestures will be mimed using the same equipment as in GAE group. Superficial femoral artery catheterization, selective catheterization of target arteries and emulsion injection will be mimicked by the interventional radiologist (table movements, syringes manipulation) to keep the patient blind from the actual treatment.
44 patients will be allocated to sham group (2:1 randomization). Receives: Procedure: Sham-operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization.
VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: 3 months
Secondary outcomes (15)
Change of pain assessed by a Visual Analogue Scale (VAS) at 1 month compared to randomization.
VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: 1 month
Change of pain assessed by a Visual Analogue Scale (VAS) at 6 months compared to randomization.
VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: 6 months
Change of pain assessed by a Visual Analogue Scale (VAS) at 12 months compared to randomization.
VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: 12 months
Change of the patient's global assessment of her/his health measured by the Visual Analogue Scale of EQ-5D questionnaire (EQ VAS) at 1, 3, 6, 12 months compared to randomization.
EQ-5D questionnaire is a validated, self-reported instrument assessing "today" health-related quality of life. EQ VAS is the second part of EQ-5D, consisting in a Visual Analogue Scale of health. Score ranges from 0 (worst health) to 100 (best health).
Measured: Up to 12 months
Change of the Western Ontario and McMaster Universities Arthritis (WOMAC) total and sub-scores (pain, function,stiffness) at 1, 3, 6, 12 months compared to randomization.
WOMAC questionnaire is a validated, self-reported instrument assessing the daily condition of patients with osteoarthritis of the lower limb. It has a multidimensional scale comprising 24 items grouped into three dimensions: pain (5 items), stiffness (2 items), and physical functioning (17 items).
Likert scale will be normalized to 100. Scores ranges from 0 (no impairment) to 100 (severe impairment).
Measured: Up to 12 months
Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores at 3 months compared to randomization.
KOOS questionnaire is a validated, self-reported instrument assessing the daily condition of patients with osteoarthritis of the lower limb. It has a multidimensional scale comprising 42 items grouped into five dimensions: pain (9 items), symptoms (7 items), activities of daily living function (17 items), sport and recreation function (5 items), quality of life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures.
Measured: 3 months
Change of the Hospital Anxiety and Depression (HAD) score and sub-scores at 3 months compared to randomization.
HAD questionnaire is a validated, self-reported instrument assessing the levels of anxiety and depression. It has a multidimensional scale comprising 14 items grouped into two dimensions: anxiety (7 items), and depression (7 items). Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. Total score ranges from 0 (no impairment) to 42 (severe impairement). A total sub-scale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: 3 months
Change of semi-quantitative MRI scoring at 6 months compared to randomization.
Semi-quantitative MRI scoring may include Whole-Organ Magnetic Resonance Imaging Score (WORMS), Knee Osteoarthritis Scoring System (KOSS), Boston-Leeds Osteoarthritis Knee Scoring (BLOKS), MRI Osteoarthritis Knee Score (MOAKS).
Measured: 6 months
Description of pain medication at Month 1, 3, 6, 12.
Pain medication will be described using analgesic level.
Measured: Up to 12 months
Description of non-pharmacological treatments for target knee in both groups at 1, 3, 6, and 12 months.
Non-pharmacological interventions may include, but are not limited to, physiotherapy, osteopathy, acupuncture, massage, electroanalgesia, laser therapy, low-level light therapy, meditation.
Measured: Up to 12 months
Number of responder patients under OMERACT-OARSI definition in both groups at 3, 6 and 12 months.
A patient is defined as responder under OMERACT-OARSI criteria if one of the following conditions is satisfied:
- Improvement in pain (0-100 mm VAS) or in WOMAC function score ≥50% and absolute change ≥20 is observed or
- Improvement in at least 2 of the 3 following conditions:
- Pain (0-100 mm VAS) ≥20% and absolute change ≥10
- WOMAC function score ≥20% and absolute change ≥10
- Patient's global assessment of her/his health (0-100 mm EQ-5D VAS) ≥20% and absolute change ≥10
Measured: Up to 12 months
Number of patients reaching an acceptable symptom state (PASS) in both groups at 3, 6, and 12 months.
PASS is defined for each patient reported outcome as:
- Pain (0-100 mm VAS) ≤32.3,
- Patients global assessment of her/his health (0-100 mm EQ-5D VAS) ≤32,
- WOMAC function score (0-100) ≤31.
Measured: Up to 12 months
Number and description of adverse events and serious adverse events at 1, 3, 6 and 12 months.
Adverse events are defined according to Article 2 of the Regulation (EU) No 536/2014. Intensity of adverse events will be graded using Clavien-Dindo classification and CTCAE v 5.0.
Measured: Up to 12 months
Description of target knee events in both groups at 6 and 12 months.
Events of interest includes intra-articular injections, embolization, surgery.
Measured: Up to 12 months
Incremental efficiency of genicular arteries embolization compared to sham treatment (medico-economic analysis).
Medico-economic study: incremental cost utility ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Sep 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, multicenter trial comparing GAE using an ethiodized oil-based emulsion with a sham procedure in patients with symptomatic knee osteoarthritis. Randomization in a 2:1 ratio of GAE using an ethiodized oil-based emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score (2-3 versus 4).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Marc SAPOVAL, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497140
- Sponsor's protocol ID
- APHP230828
- Other IDs
- PHRC-22-0033, 2023-508844-24-00, 2023
- Acronym
- LIPIOJOINT-2
- Status last verified
- Oct 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06497140
- Acronym / sponsor ID
- LIPIOJOINT-2 / APHP230828
- Conditions
- Knee Osteoarthritis
- Keywords
- Embolization, Pain, Randomized sham-controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 11 Jul 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.
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 (clinicaltrials.gov: 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.
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 inclusion/non-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 2:1 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, multicenter trial comparing GAE using an ethiodized oil-based emulsion with a sham procedure in patients with symptomatic knee osteoarthritis. Randomization in a 2:1 ratio of GAE using an ethiodized oil-based emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score (2-3 versus 4).
| Arm | Type | Receives |
|---|---|---|
| Embolization group | Experimental | Drug: Ethiodized Oil-based emulsionGenicular arteries embolization of the target knee will be performed using an ethiodized oil-based emulsion (3:1 mix of ethiodized oil and contrast agent ioversol 300 mgI/ml); 86 patients will be allocated to embolization group (2:1 randomization). |
| Sham group | Sham comparator | Procedure: Sham-operationAll the gestures will be mimed using the same equipment as in GAE group. Superficial femoral artery catheterization, selective catheterization of target arteries and emulsion injection will be mimicked by the interventional radiologist (table movements, syringes manipulation) to keep the patient blind from the actual treatment. 44 patients will be allocated to sham group (2:1 randomization). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
- Radiographic Kellgren and Lawrence score ≥ 2 (6)
- VAS pain score ≥ 40 mm (scale 0-100 mm)
- Previous intra-articular injection in the target knee
- Patient not eligible to knee surgery
Key exclusion criteria (17 listed)
- Intra-articular injection of any product in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Any inflammatory joint disease other than osteoarthritis
- Any contra-indication to puncture of the ipsilateral femoral artery
- Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
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 |
|---|---|---|
| Ethiodized Oil-based emulsionEmbolization of genicular arteries | Drug | Embolization group |
| Sham-operationMimicked catheterization and embolization of genicular arteries | Procedure or surgery | Sham group |
Primary outcome
Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization.
Time frame: 3 months
VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).
15 secondary outcomes
Change of pain assessed by a Visual Analogue Scale (VAS) at 1 month compared to randomization.
Time frame: 1 month
Change of pain assessed by a Visual Analogue Scale (VAS) at 6 months compared to randomization.
Time frame: 6 months
Change of pain assessed by a Visual Analogue Scale (VAS) at 12 months compared to randomization.
Time frame: 12 months
Change of the patient's global assessment of her/his health measured by the Visual Analogue Scale of EQ-5D questionnaire (EQ VAS) at 1, 3, 6, 12 months compared to randomization.
Time frame: Up to 12 months
Change of the Western Ontario and McMaster Universities Arthritis (WOMAC) total and sub-scores (pain, function,stiffness) at 1, 3, 6, 12 months compared to randomization.
Time frame: Up to 12 months
Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores at 3 months compared to randomization.
Time frame: 3 months
Change of the Hospital Anxiety and Depression (HAD) score and sub-scores at 3 months compared to randomization.
Time frame: 3 months
Change of semi-quantitative MRI scoring at 6 months compared to randomization.
Time frame: 6 months
Description of pain medication at Month 1, 3, 6, 12.
Time frame: Up to 12 months
Description of non-pharmacological treatments for target knee in both groups at 1, 3, 6, and 12 months.
Time frame: Up to 12 months
Number of responder patients under OMERACT-OARSI definition in both groups at 3, 6 and 12 months.
Time frame: Up to 12 months
Number of patients reaching an acceptable symptom state (PASS) in both groups at 3, 6, and 12 months.
Time frame: Up to 12 months
Number and description of adverse events and serious adverse events at 1, 3, 6 and 12 months.
Time frame: Up to 12 months
Description of target knee events in both groups at 6 and 12 months.
Time frame: Up to 12 months
Incremental efficiency of genicular arteries embolization compared to sham treatment (medico-economic analysis).
Time frame: 6 months
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 15 Oct 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
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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.
Marc SAPOVAL, MD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethiodized Oil-based emulsion in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 9 inclusion and 17 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Touria EL AAMRI (0140271848, touria.el-aamri@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization. (time frame: 3 months). 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 15 Oct 2024.