Advanced Degeneration of the Hip JointOR3ONCT04325022
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
An observational study of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint, run by Smith & Nephew, Inc. at 12 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Degeneration of the Hip Joint, Revision of the Hip Joint
- What is being tested?
- Primary Total Hip Arthroplasty and Revision Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 177 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 27 Jul 2020to 31 Jan 2035
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement
Who may be able to join
- All subjects:
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement.
- Subject is skeletally mature in the Investigator's judgement.
- Subject is 18 - 80 years old (inclusive).
- Subject has any of the following conditions:
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis (RA);
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- Fracture or avascular necrosis of the femoral head;
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- All forms of osteoarthritis (OA);
- Patients with hips at risk of dislocation;
- Femoral neck fracture or proximal hip joint fracture.
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
- Subject has all required study pre-operative and operative data available in their medical record for collection if consent is given after their THA surgery.
- Revision Subjects:
- Subject has a REDAPT™ Modular Shell implanted which does not require revision or will receive a REDAPT™ Modular Shell during revision THA.
- Subject has a S+N compatible stem which does not require revision or will receive a S+N compatible stem during revision THA.
Who cannot join
- All subjects:
- Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
- blood supply limitations;
- insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia;
- infections or other conditions which may lead to increased bone resorption.
- Subject has dysplasia of hip joint with CROWE Grade III, IV.
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- Subject has bodily disease(s) that may interfere with THA survival or outcome.
- Subject has life expectancy of less than 10 years.
- Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
- Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
- Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Subject has an active infection - systemic or at the site of intended surgery.
- Subject has a Body Mass Index > 40.0 kg/m².
- Subject has a known allergy to any component of the devices used in the study.
- Subject is pregnant or breast feeding.
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
- Revision Subjects:
- Subject has inadequate implant support with an increased risk of implant failure if support is not achieved, poor bone quality exists, or smaller sized implants are utilized.
- Subject needs revision of a fractured ceramic head or liner.
- Subject was already enrolled into this study as primary THA case.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States6 sites
St. David's Center for Hip and Knee Replacement
Austin, Texas, 78705
University of Kentucky
Lexington, Kentucky, 40508
NYU Langone Health
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 69198
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
Australia3 sites
Mater Health Services
Brisbane, Queensland, 4101
Calvary John James Hospital
Deakin, 2600
Royal Perth Hospital
Perth, Western Australia, 6000
Canada2 sites
South Health Campus, Calgary
Calgary, Alberta, T3M127
St Michael's Hospital
Toronto, Ontario, M5C1R6
About this study
Official title: Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures
The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.
- Being tested
- Primary Total Hip Arthroplasty, Revision Total Hip Arthroplasty
- Keywords
- OR3O, THA, Dual Mobility, hip revision, hip replacement, hip joint, hip implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Total Hip ArthroplastyDevice
Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
Revision Total Hip ArthroplastyDevice
Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
| Study group | Role | What they receive |
|---|---|---|
| Primary Total Hip Arthroplasty (THA) | OR3O Dual Mobility System used in primary THA Receives: Device: Primary Total Hip Arthroplasty | |
| Revision Total Hip Arthroplasty (THA) | OR3O Dual Mobility System used in revision THA Receives: Device: Revision Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of Primary Total Hip Arthroplasty (THA)
Assess survivorship of the OR3O™ Dual Mobility System at 2 years post implantation in Primary THA procedures. Survivorship is defined as no revision of the Acetabular Implant and OR3O™ Liner.
Measured: 2 years
Secondary outcomes (16)
Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
Survivorship of the following specific components will be presented individually: OR3O™Dual Mobility System, Acetabular Shell, Femoral head. The endpoint of interest is time to occurrence of a revision of the specific component due to any reason.
Measured: up to 10 years
Harris Hip Score (HHS)
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Total scores range from 0 (worst) to 100 (best). The total scores and scores for each of the domains will be presented. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion (2 items, 0-5 points). Total mHHHs scores range from 0 (worst) to 95 (best). The total mHHS score maybe used in place of the total HHS score.
Measured: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Five-level EuroQol five-dimensional (EQ-5D-5L) score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas.
The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
The HOOS JR. is a short-form survey based on the Hip Disability and Osteoarthritis Outcome Score (HOOS) that specifically focuses on the outcome after THA. HOOS JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes - no, mild, moderate, severe, extreme) and each question gets a score from 0 to 4. An interval score from 0-100 (0 indicating total hip disability and 100 indicating perfect hip health) is calculated (15).
Measured: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Forgotten Joint Score 12 (FJS-12)
The Forgotten Joint Score 12 (FJS-12) is a self-administered score where subjects are asked to rate their awareness of their hip arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced hip joint during the activities of daily living (i.e., higher score is a better outcome).
Measured: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Acetabular Cup Migration
Acetabular Cup Migration will be assessed from radiographs with the following definitions:
0 - Absent: No evidence of acetabular cup migration ≥ 3 mm from baseline
1 - Present: Presence of acetabular cup migration ≥ 3mm from baseline
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Femoral Stem Subsidence
Femoral Stem Subsidence will be assessed from radiographs with the following definitions:
0 - Absent: No evidence of inferior movement of the femoral stem ≥ 3mm.
1 - Present: Presence of inferior movement of the femoral stem compared to previously available imaging ≥ 3mm.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osseointegration Status - Acetabular Cup
Osseointegration Status - Acetabular Cup will be assessed from radiographs with the following definitions:
0 - Absent: Absence of all radiographic signs or presence of only one radiographic sign of acetabular cup osseointegration
- - Partial: Presence of two radiographic signs of acetabular cup osseointegration.
- - Complete: Presence of three or more radiographic signs of acetabular cup osseointegration.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Acetabular Cup Loosening
Acetabular Cup Loosening will be assessed from radiographs with the following definitions:
0 - Absent: No evidence of specific imaging features of loosening at the acetabular bone-implant interface including significant radiolucency or change in position of the acetabular cup indicating a loss of fixation.
1 - Present: Presence of apparent imaging features of loosening at the acetabular bone-implant interface including significant radiolucency or change in position of the acetabular cup indicating a loss of fixation.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Device Integrity
Device Integrity will be assessed from radiographs with the following definitions:
0 - Intact: No evidence of fracture, breakage or disassembly of any device component.
1 - Failed: Presence of fracture, breakage or disassembly of one or more device components.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Progressive Radiolucency Acetabular Zones
Progressive Radiolucency in all acetabular zones will be assessed from radiographs with the following definitions:
0 - None: No evidence of an increase in width of the radiolucency > 1 mm
1 - Present: Presence of an increase in width of the radiolucency > 1 mm
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Progressive Radiolucency Femoral Zones
Progressive Radiolucency in all femoral zones will be assessed from radiographs with the following definitions:
0 - None: No evidence of an increase in width of the radiolucency > 1 mm
1 - Present: Presence of an increase in width of the radiolucency > 1 mm
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osteolysis - Acetabular Cup
Osteolysis Acetabular Cup will be assessed from radiographs with the following definitions:
0 - None: No evidence of a ballooning / scalloping, progressive, periacetabular, bony destructive lesion with a maximum dimension > 5mm.
1 - Present: Presence of a ballooning / scalloping, progressive, periacetabular, bony destructive lesion with a maximum dimension > 5mm.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osteolysis - Femoral Stem
Osteolysis Femoral Stem will be assessed from radiographs with the following definitions:
0 - None: No evidence of a ballooning / scalloping, progressive, perifemoral, bony destructive lesion with a maximum dimension > 5mm.
1 - Present: Presence of a ballooning / scalloping, progressive, perifemoral, bony destructive lesion with a maximum dimension > 5mm.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Anatomic Fracture
Anatomic Fracture will be assessed from radiographs with the following definitions:
0 - Absent: No evidence of anatomic fracture or other related complication.
1 - Present: One or more of the following conditions are present: pelvic bone fracture or femoral bone fracture.
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Heterotopic Ossification
Heterotopic Ossification will be assessed from radiographs with the following definitions:
0 - None: No evidence of heterotopic bone formation
- - Grade 1: (Class I) Islands of bone within the soft tissue about the hip
- - Grade 2: (Class II) Bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter between opposing bone surfaces.
- - Grade 3: (Class III) Bone spurs from the pelvis or proximal end of the femur, reducing the space between opossing bone surfaces to less than 1 cm.
- - Grade 4: (Class IV) apparent bone ankylosis of the hip
Measured: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start27 Jul 2020
- Primary completion23 Feb 2026
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Degeneration of the Hip JointStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ran Schwarzkopf, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325022
- Sponsor's protocol ID
- OR3O.2019.08
- Acronym
- OR3O
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2020
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures
- ClinicalTrials.gov ID
- NCT04325022
- Acronym / sponsor ID
- OR3O / OR3O.2019.08
- Keywords
- OR3O, THA, Dual Mobility, hip revision, hip replacement, hip joint, hip implant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 27 Mar 2020 (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 purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Total Hip Arthroplasty (THA) | – | Device: Primary Total Hip ArthroplastyOR3O Dual Mobility System used in primary THA |
| Revision Total Hip Arthroplasty (THA) | – | Device: Revision Total Hip ArthroplastyOR3O Dual Mobility System used in revision THA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement
Key inclusion criteria (17 listed)
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement.
- Subject is skeletally mature in the Investigator's judgement.
- Subject is 18 - 80 years old (inclusive).
- Subject has any of the following conditions:
- Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
Key exclusion criteria (21 listed)
- Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
- Subject has dysplasia of hip joint with CROWE Grade III, IV.
- Subject has bodily disease(s) that may interfere with THA survival or outcome.
- Subject has life expectancy of less than 10 years.
- Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
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 |
|---|---|---|
| Primary Total Hip ArthroplastyPrimary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components | Device | Primary Total Hip Arthroplasty (THA) |
| Revision Total Hip ArthroplastyRevision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components | Device | Revision Total Hip Arthroplasty (THA) |
Primary outcome
Survivorship of Primary Total Hip Arthroplasty (THA)
Time frame: 2 years
Assess survivorship of the OR3O™ Dual Mobility System at 2 years post implantation in Primary THA procedures. Survivorship is defined as no revision of the Acetabular Implant and OR3O™ Liner.
16 secondary outcomes
Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head)
Time frame: up to 10 years
Harris Hip Score (HHS)
Time frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Five-level EuroQol five-dimensional (EQ-5D-5L) score
Time frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
Time frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Forgotten Joint Score 12 (FJS-12)
Time frame: Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Acetabular Cup Migration
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Femoral Stem Subsidence
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osseointegration Status - Acetabular Cup
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Acetabular Cup Loosening
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Device Integrity
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Progressive Radiolucency Acetabular Zones
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Progressive Radiolucency Femoral Zones
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osteolysis - Acetabular Cup
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Osteolysis - Femoral Stem
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Anatomic Fracture
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
Radiographic Assessment - Heterotopic Ossification
Time frame: 6 weeks, 1 year, 2 years, 5 years, and 10 years
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
Ran Schwarzkopf, MD principal investigator
NYU Langone Health
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint, run by Smith & Nephew, Inc. at 12 sites in 4 countries.
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 17 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Canada, Hong Kong. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship of Primary Total Hip Arthroplasty (THA) (time frame: 2 years). 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 2 Sep 2026.