Amputation of Lower LimbNCT06938087
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A study testing 3D printed prosthesis foot and Current prosthesis foot in people with Amputation of Lower Limb, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
Trial summary
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation of Lower Limb
- What is being tested?
- 3D printed prosthesis foot and Current prosthesis foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2025to 7 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Monolateral below knee amputation
- Mobility level: K3 or K4
- Age: 18-65 years old
- Maximum weigth: 100 Kg
- Collaborative subject
- Clinically stable stump
Who cannot join
- Pregnant
- Not able to understand written and oral instructions
- Problems to the stump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess Safety and Performances of a Energy Storing and Return (ESAR) Prosthetic Foot Made in Additive Manufacturing
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. This type of prosthesis is designed to allow patients to perform daily activities, even very dynamic ones, with greater ease and efficiency. The distinguishing feature of a dynamic energy storage and return prosthesis is the presence of a system that accumulates mechanical energy during the support phase on the ground and returns it during the push phase, increasing the amount of push itself. In foot prostheses, it is common to use carbon fiber blades or springs that deform during the support of the foot and then restore themselves, returning elastic energy during the subsequent push. This helps reduce the effort required to walk and allows for more fluid and natural movements. Additive Manufacturing (AM) technology is ideal for highly customized and high-value production. Orthoses/prostheses are particularly suited to exploit the potential of this technology. However, the lack of functional materials that meet different design needs, such as structure and comfort of the devices, has limited the use of AM mainly in orthoses. AM is promising for orthoses due to its customization capability and reduced production costs compared to traditional solutions. In particular, it has been shown how continuous filament carbon printing can lead to the creation of prostheses that have dynamic and energy return characteristics similar to or even superior to commercial ones. The present pilot clinical investigation aims to provide indications regarding the safety and performance of the 3D printed prosthesis - named PROFIL - in a real-world scenario. The state of the art has not yet defined the performance and safety of 3D printed prostheses with thermoplastic materials and continuous carbon fiber. Since greater comfort and the possibility of performing physical activity more easily with the use of these devices is expected, it is considered of interest for clinical practice to evaluate these prostheses. The primary objective of the study is therefore to evaluate the safety and performance of the device during walking on flat surfaces and more demanding tasks. The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ascending and descending ramps or steps) by mean of fiber-glass sensors integrated in the prosthesis foot.
- Conditions
- Amputation of Lower Limb
- Being tested
- 3D printed prosthesis foot, Current prosthesis foot
- Keywords
- Safety, Lower limb amputation, Additive manufacturing, Prosthesis foot, Performances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed prosthesis footDevice
Energy storage and restoration 3D printed prosthesis foot
Current prosthesis footDevice
Energy storage and restitution prosthesis foot made in carbon fibers blades
| Study group | Role | What they receive |
|---|---|---|
| PROFIL prosthesis foot | Experimental | Recruited subjects with below kenen amputation wearing the experimental prosthesis foot (PROFIL) Receives: Device: 3D printed prosthesis foot |
| Current prosthesis foot (PROFLEX XC) | Active comparator | Recruited subjects with below knee amputation wearing the currently used prosthesis foot (PROFIL) Receives: Device: Current prosthesis foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Occurred During Use of the Intervention Prosthesis Foot
Adverse events may be: falling, stumbling, lower back pain as consequence of the prosthesis foot use, stump pain as consequence of the prosthesis foot use, breakage of the prosthesis foot
Measured: Day 1 and Day 2
Change From Comparator of Lower Limb Joint Angles Measured With Inertial Measurements Units (IMUs)
The IMUs record joints kinematics while subjects perform a series of motor tasks, i.e. walk of flat surfaces at a self-selected speed and ascend/descend stairs and ramps. In particular, the following variables are measured: range of motion of ankle joint (prosthetic ankle), knee joint, and hip joint of the impaired lower limb. The measured angles are normalized on a gait cycle (0% = heel strike, 100% = toe off). The outocome variable is computed as mean difference between the normalized measured angles and the normalized reference value taken from the literature.
Measured: Day 1 and Day 2
Change From Comparator of Lower Limb Joint Angles Measured With an Optoelectronic System
The optoelectronic system records joints kinematics while subjects walk of a flat surfaces at a self-selected speed. In particular, the following variables are measured: range of motion of ankle joint (prosthetic ankle), knee joint, and hip joint of the impaired lower limb. The measured angles are normalized on a gait cycle (0% = heel strike, 100% = toe off). The outocome variable is computed as mean difference between the normalized measured angles and the normalized reference value taken from the literature.
Measured: Day 1 and Day 2
Change From Comparator of Gait Quality Wihile Ascending Ramps With Hill Assessment Index (HAI)
Hill Assessment Index (HAI) is a 12-points ordinal scale used to evaluate ramp ascending quality; the higher the score the better the gait quality while ascending ramps (0 = cannot do/refuse to do, 11 = even step, without assistive device) .
Measured: Day 1 and Day 2
Change From Comparator of Gait Quality While Ascending Stairs With Stair Ascending Index (SAI)
Stair Ascending Index (SAI) is 14-points ordinal scale used to quantify stair ascending qualty; the higher the score the better the gait quality while ascending stairs (0 = cannot do/refuse to do, 13 = Without rail or assistive device, step-over-step pattern)
Measured: Day 1 and Day 2
Change From Comparator of Equilibrium in Orthostatism by Mean of Force Plates
The subject is asked to stand still on a force plate for 30 seconds. The sway path of the Centre of Pressure (COP) is recorded. The higher the valure the sway path, the lower the equilibrium in orthostatism. This outcome measure is performed with the eyes open and closed
Measured: Day 1 and Day 2
Change From Comparator of Load Simmetry While Standing up/Sitting Down From/on a Chiar by Mean of Force Plates
The subject is asked to sit on a chair with both the feets (sound foot and prosthesis foot) on different force plates. At the "Start" signal, the subject stands up, stands still for 5 seconds and sits down. The weigth distribution on the lower limbs is recorded during the entire task. The symmetry index is computed as the ratio between: the difference between the load peak of the ground reaction force (GRF) measured in the sound side and the load peak of the ground reaction force (GRF) measured in the impaired side ON the sum between the load peak of the ground reaction force (GRF) measured in the sound side and the load peak of the ground reaction force (GRF) measured in the impaired side.
Asymmetry index = [(peak GRF sound - peak GRF impaired) / (peak GRF sound + peak GRF impaired)]*100%
Measured: Day 1 and Day 2
Change From Comparator of Amputee Mobility Predictor (AMP-PRO)
AMP is a 21-item objectve measure in which static and dynamic sitting and standing activities, as well as transfer and gait skills of progressing difficulty are performed. Score range is 0-47. Higher scores indicate better mobility. Based on the final score, 4 groups are defined (K1 = 15-26, K2 = 27-36, K3 = 37-42, K4 = 43-47).
Measured: Day 1 and Day 2
Change From Comparator of Functional Mobility Measured With the L-test
The subject starts from a sitting position. At the "Start" signal, the subject stands up from the chair, walks in a closed 10-meters L-shaped path, and sits down on the same chair. The time necessary to complete the path is measured with a stopwatch. The lower the time to complete the path, the higher the functional mobility.
Measured: Day 1 and Day 2
Secondary outcomes (1)
Change From Comparator of Usability of the Prosthesis Foot
Usability is measured with an ad hoc custom-made 6-items questionnaire. Each item ranges 1 to 5. To compute the final score, each item is summed up (total range: 6-30). The higher the score, the better the usability.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start5 May 2025
- Primary completion7 Jun 2025
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Amputation of Lower LimbStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto per i Polimeri Compositi e Biomateriali (CNR-IPCB), Istituto di Chimica della Materia Condensata e di Tecnologie per l'Energia (CNR-ICMATE)
- Responsible party
- Principal investigator, Emanuele Gruppioni, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938087
- Sponsor's protocol ID
- CP-PAI-01-23
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anthropometric characteristics Kinematics data measured via IMUs, optoelectronic system and force plates Scores of PROMs
Publications
Manero A, Smith P, Sparkman J, Dombrowski M, Courbin D, Kester A, Womack I, Chi A. Implementation of 3D Printing Technology in the Field of Prosthetics: Past, Present, and Future. Int J Environ Res Public Health. 2019 May 10;16(9):1641. doi: 10.3390/ijerph16091641.
PubMed 31083479South BJ, Fey NP, Bosker G, Neptune RR. Manufacture of energy storage and return prosthetic feet using selective laser sintering. J Biomech Eng. 2010 Jan;132(1):015001. doi: 10.1115/1.4000166.
PubMed 20524754Klute GK, Berge JS, Orendurff MS, Williams RM, Czerniecki JM. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006 May;87(5):717-22. doi: 10.1016/j.apmr.2006.02.007.
PubMed 16635636Versluys R, Beyl P, Van Damme M, Desomer A, Van Ham R, Lefeber D. Prosthetic feet: state-of-the-art review and the importance of mimicking human ankle-foot biomechanics. Disabil Rehabil Assist Technol. 2009 Mar;4(2):65-75. doi: 10.1080/17483100802715092.
PubMed 19253096Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7.
PubMed 12084537
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Safety and Performances of a Energy Storing and Return (ESAR) Prosthetic Foot Made in Additive Manufacturing
- ClinicalTrials.gov ID
- NCT06938087
- Acronym / sponsor ID
- CP-PAI-01-23
- Conditions
- Amputation of Lower Limb
- Keywords
- Safety, Lower limb amputation, Additive manufacturing, Prosthesis foot, Performances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Collaborators
- Istituto per i Polimeri Compositi e Biomateriali (CNR-IPCB), Istituto di Chimica della Materia Condensata e di Tecnologie per l'Energia (CNR-ICMATE)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. This type of prosthesis is designed to allow patients to perform daily activities, even very dynamic ones, with greater ease and efficiency. The distinguishing feature of a dynamic energy storage and return prosthesis is the presence of a system that accumulates mechanical energy during the support phase on the ground and returns it during the push phase, increasing the amount of push itself. In foot prostheses, it is common to use carbon fiber blades or springs that deform during the support of the foot and then restore themselves, returning elastic energy during the subsequent push. This helps reduce the effort required to walk and allows for more fluid and natural movements. Additive Manufacturing (AM) technology is ideal for highly customized and high-value production. Orthoses/prostheses are particularly suited to exploit the potential of this technology. However, the lack of functional materials that meet different design needs, such as structure and comfort of the devices, has limited the use of AM mainly in orthoses. AM is promising for orthoses due to its customization capability and reduced production costs compared to traditional solutions. In particular, it has been shown how continuous filament carbon printing can lead to the creation of prostheses that have dynamic and energy return characteristics similar to or even superior to commercial ones. The present pilot clinical investigation aims to provide indications regarding the safety and performance of the 3D printed prosthesis - named PROFIL - in a real-world scenario. The state of the art has not yet defined the performance and safety of 3D printed prostheses with thermoplastic materials and continuous carbon fiber. Since greater comfort and the possibility of performing physical activity more easily with the use of these devices is expected, it is considered of interest for clinical practice to evaluate these prostheses. The primary objective of the study is therefore to evaluate the safety and performance of the device during walking on flat surfaces and more demanding tasks. The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ascending and descending ramps or steps) by mean of fiber-glass sensors integrated in the prosthesis foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROFIL prosthesis foot | Experimental | Device: 3D printed prosthesis footRecruited subjects with below kenen amputation wearing the experimental prosthesis foot (PROFIL) |
| Current prosthesis foot (PROFLEX XC) | Active comparator | Device: Current prosthesis footRecruited subjects with below knee amputation wearing the currently used prosthesis foot (PROFIL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Monolateral below knee amputation
- Mobility level: K3 or K4
- Age: 18-65 years old
- Maximum weigth: 100 Kg
- Collaborative subject
Key exclusion criteria (3 listed)
- Pregnant
- Not able to understand written and oral instructions
- Problems to the stump
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 |
|---|---|---|
| 3D printed prosthesis footEnergy storage and restoration 3D printed prosthesis foot | Device | PROFIL prosthesis foot |
| Current prosthesis footEnergy storage and restitution prosthesis foot made in carbon fibers blades | Device | Current prosthesis foot (PROFLEX XC) |
Primary outcome
Number of Adverse Events Occurred During Use of the Intervention Prosthesis Foot
Time frame: Day 1 and Day 2
Adverse events may be: falling, stumbling, lower back pain as consequence of the prosthesis foot use, stump pain as consequence of the prosthesis foot use, breakage of the prosthesis foot
Change From Comparator of Lower Limb Joint Angles Measured With Inertial Measurements Units (IMUs)
Time frame: Day 1 and Day 2
The IMUs record joints kinematics while subjects perform a series of motor tasks, i.e. walk of flat surfaces at a self-selected speed and ascend/descend stairs and ramps. In particular, the following variables are measured: range of motion of ankle joint (prosthetic ankle), knee joint, and hip joint of the impaired lower limb. The measured angles are normalized on a gait cycle (0% = heel strike, 100% = toe off). The outocome variable is computed as mean difference between the normalized measured angles and the normalized reference value taken from the literature.
Change From Comparator of Lower Limb Joint Angles Measured With an Optoelectronic System
Time frame: Day 1 and Day 2
The optoelectronic system records joints kinematics while subjects walk of a flat surfaces at a self-selected speed. In particular, the following variables are measured: range of motion of ankle joint (prosthetic ankle), knee joint, and hip joint of the impaired lower limb. The measured angles are normalized on a gait cycle (0% = heel strike, 100% = toe off). The outocome variable is computed as mean difference between the normalized measured angles and the normalized reference value taken from the literature.
Change From Comparator of Gait Quality Wihile Ascending Ramps With Hill Assessment Index (HAI)
Time frame: Day 1 and Day 2
Hill Assessment Index (HAI) is a 12-points ordinal scale used to evaluate ramp ascending quality; the higher the score the better the gait quality while ascending ramps (0 = cannot do/refuse to do, 11 = even step, without assistive device) .
Change From Comparator of Gait Quality While Ascending Stairs With Stair Ascending Index (SAI)
Time frame: Day 1 and Day 2
Stair Ascending Index (SAI) is 14-points ordinal scale used to quantify stair ascending qualty; the higher the score the better the gait quality while ascending stairs (0 = cannot do/refuse to do, 13 = Without rail or assistive device, step-over-step pattern)
Change From Comparator of Equilibrium in Orthostatism by Mean of Force Plates
Time frame: Day 1 and Day 2
The subject is asked to stand still on a force plate for 30 seconds. The sway path of the Centre of Pressure (COP) is recorded. The higher the valure the sway path, the lower the equilibrium in orthostatism. This outcome measure is performed with the eyes open and closed
Change From Comparator of Load Simmetry While Standing up/Sitting Down From/on a Chiar by Mean of Force Plates
Time frame: Day 1 and Day 2
The subject is asked to sit on a chair with both the feets (sound foot and prosthesis foot) on different force plates. At the "Start" signal, the subject stands up, stands still for 5 seconds and sits down. The weigth distribution on the lower limbs is recorded during the entire task. The symmetry index is computed as the ratio between: the difference between the load peak of the ground reaction force (GRF) measured in the sound side and the load peak of the ground reaction force (GRF) measured in the impaired side ON the sum between the load peak of the ground reaction force (GRF) measured in the sound side and the load peak of the ground reaction force (GRF) measured in the impaired side. Asymmetry index = [(peak GRF sound - peak GRF impaired) / (peak GRF sound + peak GRF impaired)]*100%
Change From Comparator of Amputee Mobility Predictor (AMP-PRO)
Time frame: Day 1 and Day 2
AMP is a 21-item objectve measure in which static and dynamic sitting and standing activities, as well as transfer and gait skills of progressing difficulty are performed. Score range is 0-47. Higher scores indicate better mobility. Based on the final score, 4 groups are defined (K1 = 15-26, K2 = 27-36, K3 = 37-42, K4 = 43-47).
Change From Comparator of Functional Mobility Measured With the L-test
Time frame: Day 1 and Day 2
The subject starts from a sitting position. At the "Start" signal, the subject stands up from the chair, walks in a closed 10-meters L-shaped path, and sits down on the same chair. The time necessary to complete the path is measured with a stopwatch. The lower the time to complete the path, the higher the functional mobility.
1 secondary outcome
Change From Comparator of Usability of the Prosthesis Foot
Time frame: Day 1 and Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31083479Manero A, Smith P, Sparkman J, Dombrowski M, Courbin D, Kester A, Womack I, Chi A. Implementation of 3D Printing Technology in the Field of Prosthetics: Past, Present, and Future. Int J Environ Res Public Health. 2019 May 10;16(9):1641. doi: 10.3390/ijerph16091641.
- Background: PubMed 20524754South BJ, Fey NP, Bosker G, Neptune RR. Manufacture of energy storage and return prosthetic feet using selective laser sintering. J Biomech Eng. 2010 Jan;132(1):015001. doi: 10.1115/1.4000166.
- Background: PubMed 16635636Klute GK, Berge JS, Orendurff MS, Williams RM, Czerniecki JM. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006 May;87(5):717-22. doi: 10.1016/j.apmr.2006.02.007.
- Background: PubMed 19253096Versluys R, Beyl P, Van Damme M, Desomer A, Van Ham R, Lefeber D. Prosthetic feet: state-of-the-art review and the importance of mimicking human ankle-foot biomechanics. Disabil Rehabil Assist Technol. 2009 Mar;4(2):65-75. doi: 10.1080/17483100802715092.
- Background: PubMed 12084537Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7.
- Individual participant dataSharing planned: Yes. Anthropometric characteristics Kinematics data measured via IMUs, optoelectronic system and force plates Scores of PROMs
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed prosthesis foot and Current prosthesis foot in people with Amputation of Lower Limb, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 27 Feb 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 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events Occurred During Use of the Intervention Prosthesis Foot (time frame: Day 1 and Day 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938087, which also lists 5 linked publications.
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 27 Feb 2026.