Trapeziometacarpal OsteoarthritisSMAGENARTNCT06781554
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
A study testing MD-Small Joints Collagen Medical Device in people with Trapeziometacarpal Osteoarthritis and Rhizarthrosis, run by Guna S.p.a at 1 site in Italy.
Trial summary
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis, Rhizarthrosis, MEDICAL DEVICE
- What is being tested?
- MD-Small Joints Collagen Medical Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 18 Nov 2024to 30 Mar 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged between 18 and 75 years;
- Subjects with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and Littler's classification);
- [N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb carpometacarpal joint that is more affected at the time of enrollment].
- Subjects with a VAS score ≥ 5; [The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!]
- Subjects with joint pain for at least 1 month;
- Subjects not using thumb carpometacarpal orthotic devices;
- Subjects agreeing not to take analgesics within 24 hours before the scheduled visits;
- Subjects capable of understanding and signing the Informed Consent.
Who cannot join
- Subjects with rheumatological conditions involving the hands;
- Subjects who have undergone hand surgery for the affected pathology;
- Subjects who have received HA injections in the thumb carpometacarpal joint in the last 3 months;
- Subjects who have taken NSAIDs in the last 7 days and/or corticosteroids in the last 30 days;
- Subjects undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;
- Subjects with neoplastic pathology;
Show all 17Show fewer
- Subjects with systemic infections;
- Subjects with uncontrolled diabetes;
- Subjects with neurological conditions that may affect active participation in the study;
- Subjects with coagulopathies or taking anticoagulants (vitamin K antagonists, heparin);
- Subjects undergoing immunosuppressive treatment;
- Subjects using drugs or abusing alcohol;
- Subjects allergic to porcine collagen;
- Female subjects who are pregnant or breastfeeding;
- Subjects participating in other clinical studies during the same period;
- Subjects unable to cooperate or for whom poor compliance is expected;
- Any condition that, in the investigator's judgment, recommends the subject's exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda Piazza dell'Ospedale Maggiore,
Milan, MI, 20135
Kamilia Laarej, Dr, 0228018359, k.laarej@guna.it
vincenzo Miranda, Dr, 0228018358, v.miranda@guna.it
About this study
Official title: Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS. "SMAGENART PILOT STUDY"
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments.
Growing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the treatment of osteoarthritis in various body districts with the intention of limiting joint hypermobility, stabilizing the structure of joint and peri-articular components, reducing pain, and consequently improving function. Several clinical studies have demonstrated that its intra-articular infiltrative use could result in pain reduction and improvement of functionality in various cases of gonarthrosis and coxarthrosis. Regarding the conservative management of symptomatic thumb base osteoarthritis, some studies, albeit on limited case series, have highlighted how the use of type I collagen at the joint and peri-articular level can lead to better control of painful symptoms, improvement in functionality, and reduction of joint instability.
Read more
Recently, Randelli F. et al. studied the in vitro effects on tenocytes induced by type I swine collagen (MD-Tissue Collagen Medical Device). In vitro results seem to demonstrate that this medical device can induce proliferation and migration of tenocytes and synthesis, maturation, and secretion of type I collagen, favoring tendon repair.
Randelli F. et al. also demonstrated the mainly mechanical activity of MD-Tissue Collagen Medical Device, which is able to induce modifications of morpho-functional properties of tenocytes.
In this Clinical Investigation, we aim to investigate the performance and safety of an injectable medical device based on type I collagen of swine origin called MD-Small Joints Collagen Medical Device, in the treatment of symptomatic thumb base osteoarthritis.
The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis. The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis, at time T6 weeks (T6w) compared to T0 (day0). A reduction of at least 30% in the VAS score is considered clinically significant.
Secondary endpoints will consist of evaluating the performance of MD-Small Joints Collagen Medical Device through:
- VAS score assessment at T3 week and T16week /FU compared to T0;
- Disability of the Arm Shoulder and Hand score assessment at T6 week and T16 week /FU compared to T0 (day0);
- Functional Index for Hand Osteoarthritis assessment at T6 week and T16 week /FU compared to T0;
- Pinch Strength Test assessment at T6 week and T16 week/FU compared to T0;
- Evaluation of analgesic drug consumption through clinical diary in various study phases;
- Assessment of Adverse Event incidence.
Read the detailed description
The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis.
STUDY DESIGN:
This multicenter pilot Clinical Investigation will be based on a One-sample design. Variables will be assessed at 4 different time points: baseline (T0), after 3 weeks (T3w), after 6 weeks (T6 weeks), and after 16 weeks (T16w/FU), which is 12 weeks after the end of the infiltrative treatment.
Subjects will be treated with one infiltration of 2ml volume at the time of enrollment (T0) and weekly for a total of 5 infiltrations.
- Being tested
- MD-Small Joints Collagen Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-Small Joints Collagen Medical DeviceDevice
The infiltrations will be performed using 2.5ml syringes and 26 gauge/13mm needles under complete aseptic conditions. The first 3 infiltrations will be carried out at both intra- and peri-articular levels by injecting MD-Small Joints Collagen Medical Device into the trapeziometacarpal joint until a counter-pressure is felt, preventing further penetration of the liquid; the remaining quantity (usually about 1ml) will be injected at the peri-articular level by retracting the needle tip. The fourth and fifth infiltrations will be performed only at the peri-articular level.
| Study group | Role | What they receive |
|---|---|---|
| MD-Small Joints Collagen Medical Device | Experimental | MD-Small Joints Collagen Medical Device intra/peri-articular infiltration of MD-Small Joints Collagen Medical Device will be performed The Investigation Plan envisages a single experimental group which will be treated with infiltrations of: MD-Small Joints Collagen Medical Device (GUNA, Milan-Italy).
Composition per 2ml: collagen of porcine origin 100 µg Excipients: Violet, NaCl, Water for injection. The subjects will be treated with 1 infiltration with a volume of 2ml at the time of enrollment (T0) and on a weekly basis for a total of 5 infiltrations. Receives: Device: MD-Small Joints Collagen Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of MD-Small Joints Collagen Medical Device in reducing pain
The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis at T6 weeks (T6w) compared to T0 (day0). A reduction in VAS score of at least 30% is considered clinically significant.
Measured: T6 week compared to T0 (day0)
Secondary outcomes (6)
evaluating the VAS performance of MD-Small Joints Collagen Medical Device
The secondary endpoints will include evaluating the VAS performance of MD-Small Joints Collagen Medical Device
Measured: VAS at T3 week and T16week/FU compared to T0 (day 0);
Evaluating DASH performance of MD-Small Joints Collagen Medical Device
Evaluating DASH performance of MD-Small Joints Collagen Medical Device at T6 week and T16 week/FU compared to T0 (day0);
Measured: DASH at T6 week and T16week /FU compared to T0(day0);
Evaluating FIHOA performance of MD-Small Joints Collagen Medical Device
Assesments FIHOA at T6 week and T16week/FU compared to T0 (day0);
.
Measured: FIHOA at T6 week and T16 week/FU compared to T0 (day0); .
Evaluation of Pinch Strength Test
Pinch Strength Test at T6 week and T16week /FU compared to T0 (day0);
Measured: Pinch Strength Test at T6 week and T16week /FU compared to T0 (day0);
Consumption of analgesics during various stages of the study;
Consumption of analgesics during various stages of the study;
Measured: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4) week 6 (T6) and week 16 (T16)
Incidence of AE
Incidence of Adverse Events
Measured: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4) week 6 (T6) and week 16 (T16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start18 Nov 2024
- Primary completion29 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guna S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781554
- Sponsor's protocol ID
- MDG20232202
- Acronym
- SMAGENART
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS. "SMAGENART PILOT STUDY"
- ClinicalTrials.gov ID
- NCT06781554
- Acronym / sponsor ID
- SMAGENART / MDG20232202
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guna S.p.aIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 29 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 17 Jan 2025 (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.
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments.
Growing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the treatment of osteoarthritis in various body districts with the intention of limiting joint hypermobility, stabilizing the structure of joint and peri-articular components, reducing pain, and consequently improving function. Several clinical studies have demonstrated that its intra-articular infiltrative use could result in pain reduction and improvement of functionality in various cases of gonarthrosis and coxarthrosis. Regarding the conservative management of symptomatic thumb base osteoarthritis, some studies, albeit on limited case series, have highlighted how the use of type I collagen at the joint and peri-articular level can lead to better control of painful symptoms, improvement in functionality, and reduction of joint instability.
Recently, Randelli F. et al. studied the in vitro effects on tenocytes induced by type I swine collagen (MD-Tissue Collagen Medical Device). In vitro results seem to demonstrate that this medical device can induce proliferation and migration of tenocytes and synthesis, maturation, and secretion of type I collagen, favoring tendon repair.
Randelli F. et al. also demonstrated the mainly mechanical activity of MD-Tissue Collagen Medical Device, which is able to induce modifications of morpho-functional properties of tenocytes.
In this Clinical Investigation, we aim to investigate the performance and safety of an injectable medical device based on type I collagen of swine origin called MD-Small Joints Collagen Medical Device, in the treatment of symptomatic thumb base osteoarthritis.
The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis. The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis, at time T6 weeks (T6w) compared to T0 (day0). A reduction of at least 30% in the VAS score is considered clinically significant.
Secondary endpoints will consist of evaluating the performance of MD-Small Joints Collagen Medical Device through:
- VAS score assessment at T3 week and T16week /FU compared to T0;
- Disability of the Arm Shoulder and Hand score assessment at T6 week and T16 week /FU compared to T0 (day0);
- Functional Index for Hand Osteoarthritis assessment at T6 week and T16 week /FU compared to T0;
- Pinch Strength Test assessment at T6 week and T16 week/FU compared to T0;
- Evaluation of analgesic drug consumption through clinical diary in various study phases;
- Assessment of Adverse Event incidence.
Detailed description
The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis.
STUDY DESIGN:
This multicenter pilot Clinical Investigation will be based on a One-sample design. Variables will be assessed at 4 different time points: baseline (T0), after 3 weeks (T3w), after 6 weeks (T6 weeks), and after 16 weeks (T16w/FU), which is 12 weeks after the end of the infiltrative treatment.
Subjects will be treated with one infiltration of 2ml volume at the time of enrollment (T0) and weekly for a total of 5 infiltrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MD-Small Joints Collagen Medical Device | Experimental | Device: MD-Small Joints Collagen Medical DeviceMD-Small Joints Collagen Medical Device intra/peri-articular infiltration of MD-Small Joints Collagen Medical Device will be performed The Investigation Plan envisages a single experimental group which will be treated with infiltrations of: MD-Small Joints Collagen Medical Device (GUNA, Milan-Italy). Composition per 2ml: collagen of porcine origin 100 µg Excipients: Violet, NaCl, Water for injection. The subjects will be treated with 1 infiltration with a volume of 2ml at the time of enrollment (T0) and on a weekly basis for a total of 5 infiltrations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects aged between 18 and 75 years;
- Subjects with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and Littler's classification);
- [N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb carpometacarpal joint that is more affected at the time of enrollment].
- Subjects with a VAS score ≥ 5; [The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!]
- Subjects with joint pain for at least 1 month;
Key exclusion criteria (17 listed)
- Subjects with rheumatological conditions involving the hands;
- Subjects who have undergone hand surgery for the affected pathology;
- Subjects who have received HA injections in the thumb carpometacarpal joint in the last 3 months;
- Subjects who have taken NSAIDs in the last 7 days and/or corticosteroids in the last 30 days;
- Subjects undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;
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 |
|---|---|---|
| MD-Small Joints Collagen Medical DeviceThe infiltrations will be performed using 2.5ml syringes and 26 gauge/13mm needles under complete aseptic conditions. The first 3 infiltrations will be carried out at both intra- and peri-articular levels by injecting MD-Small Joints Collagen Medical Device into the trapeziometacarpal joint until a counter-pressure is felt, preventing further penetration of the liquid; the remaining quantity (usually about 1ml) will be injected at the peri-articular level by retracting the needle tip. The fourth and fifth infiltrations will be performed only at the peri-articular level. | Device | MD-Small Joints Collagen Medical Device |
Primary outcome
The performance of MD-Small Joints Collagen Medical Device in reducing pain
Time frame: T6 week compared to T0 (day0)
The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis at T6 weeks (T6w) compared to T0 (day0). A reduction in VAS score of at least 30% is considered clinically significant.
6 secondary outcomes
evaluating the VAS performance of MD-Small Joints Collagen Medical Device
Time frame: VAS at T3 week and T16week/FU compared to T0 (day 0);
Evaluating DASH performance of MD-Small Joints Collagen Medical Device
Time frame: DASH at T6 week and T16week /FU compared to T0(day0);
Evaluating FIHOA performance of MD-Small Joints Collagen Medical Device
Time frame: FIHOA at T6 week and T16 week/FU compared to T0 (day0); .
Evaluation of Pinch Strength Test
Time frame: Pinch Strength Test at T6 week and T16week /FU compared to T0 (day0);
Consumption of analgesics during various stages of the study;
Time frame: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4) week 6 (T6) and week 16 (T16)
Incidence of AE
Time frame: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4) week 6 (T6) and week 16 (T16)
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 17 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Trapeziometacarpal Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Trapeziometacarpal Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis
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.
ASST Grande Ospedale Metropolitano Niguarda Piazza dell'Ospedale Maggiore,
Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-Small Joints Collagen Medical Device in people with Trapeziometacarpal Osteoarthritis and Rhizarthrosis, run by Guna S.p.a at 1 site in Italy.
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 8 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 17 Jan 2025. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of MD-Small Joints Collagen Medical Device in reducing pain (time frame: T6 week compared to T0 (day0)). 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 17 Jan 2025.