Lower-Limb AmputationMAP-CSBNCT07530601
Evaluation of a New Articulated Prosthetic Foot: Comfort, Safety and Biomechanics in Individuals With a Lower-Limb Amputation
A study testing New Articulated Prosthetic Foot and Current Prosthetic foot in people with Lower-Limb Amputation, run by Vrije Universiteit Brussel at 2 sites in Belgium.
Trial summary
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower-Limb Amputation
- What is being tested?
- New Articulated Prosthetic Foot and Current Prosthetic foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2026to Jun 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 80 years
- Gender: Men and Women
- Level of amputation:
- Unilateral / bilateral
- Transtibial / transfemoral / knee disarticulation / hip disarticulation
- Cause of amputation:
Show all 9Show fewer
- Vascular, traumatic, cancer and congenital
- Medicare Functional Classification Level: K2-K3-K4
- Completion of post-amputation rehabilitation
Who cannot join
- Any neurological disease
- Excessive residual limb pain and wounds
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
Vrije Universiteit Brussel
Brussels, Brussels Capital, 1050
Kevin De Pauw, 475 67 82 64 ext. +32, kevin.de.pauw@vub.be
Kevin De Pauw
Axiles Bionics
Brussels, Brussels Capital, 1130
Fanny Delquignies, 6 70 69 94 23 ext. +33, fanny@axilesbionics.com
Fanny Delquignies
About this study
Official title: Multidimensional Assessment of a New Ankle-Foot Prosthesis in Daily Use: User Comfort, Safety, and Biomechanical Performance
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
Read the detailed description
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
The primary objective of this clinical investigation is to evaluate the safety, effectiveness, and comfort of the new prosthetic foot, along with user satisfaction and its impact on quality of life during daily-life activities. The study aims to determine whether the prosthetic foot can be safely and effectively integrated into the users' routine mobility, while also providing a comfortable experience that enhances overall well-being. In addition to these primary outcomes, the study will address several secondary objectives to gain a more comprehensive understanding of the device's performance. These include assessing the biomechanical characteristics of walking with the new prosthetic foot, specifically focusing on gait parameters. The investigation also aims to evaluate the device's shock absorption capabilities and its ability to support multi-axial movement, both of which are important for natural and efficient locomotion. Furthermore, the study will explore the attentional demand required when walking with the new prosthetic foot, providing insight into how the device affects mental engagement during ambulation. Lastly, the influence of prosthetic alignment on performance and user experience will be examined to optimize fitting and functionality.
Overall, the new prosthetic foot will be assessed during a variety of daily-life activities, with varying familiarization periods, allowing for a holistic evaluation of the prosthetic foot in realistic and diverse usage conditions.
- Conditions
- Lower-Limb Amputation
- Being tested
- New Articulated Prosthetic Foot, Current Prosthetic foot
- Keywords
- ankle-foot prosthesis, daily-life activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Articulated Prosthetic FootDevice
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
Current Prosthetic footDevice
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
| Study group | Role | What they receive |
|---|---|---|
| New Articulated Prosthetic Foot | Experimental | Participants will be fitted with the new articulated prosthetic foot and follow the protocol Receives: Device: New Articulated Prosthetic Foot |
| Current Prosthetic foot | Active comparator | Participants will be fitted with their current prosthetic foot and follow the protocol Receives: Device: Current Prosthetic foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Scales: Comfort, Safety, Fatigue and Pain
Visual Analog Scale (VAS) during different activities: walking on flat ground, walking on slopes, climbing and descending stairs, and walking on uneven terrain.
VAS is between 0 and 100. Higher scores indicate higher comfort, safety, fatigue or pain.
Measured: Through study completion, a period of 3 hours.
Preference questionnaire: 5 points Likert scale
Comparison between the current foot and the new articulated foot in several areas : Mobility \& Functionality, Comfort \& Fit, Stability \& Safety, Mechanical Performance. Likert scale is between 1 and 5, where 1 indicates "Much worse", and 5 indicates "Much better".
Measured: Through study completion, a period of 3 hours.
User satisfaction questionnaire: 5 points Likert scale
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-device). Satisfaction scale is between 1 and 5, where 1 indicates "Not satisfied at all", and 5 indicates "Very satisfied".
Measured: Through study completion, a period of 3 hours.
Secondary outcomes (9)
Hill assessment index
Walking on slopes. Hill assessment index is between 0 and 11, where 0 indicates "Cannot do" and 11 indicates "Even steps without assistive device"
Measured: Through study completion, a period of 3 hours.
Stair assessment index
Climbing and descending stairs. Index goes from 0 to 13, where 0 means "Cannot do" and 13 means "Without rail and assistive device, step over step pattern".
Measured: Through study completion, a period of 3 hours.
Ankle Joint angles and angular velocities
Measured through onboard sensors (ankle encoder), in degrees and degrees/second.
Measured: Through study completion, a period of 3 hours.
Temporal Gait parameters
Step time, stance and swing time, measured in seconds through on-board sensors (IMUs).
Measured: Through study completion, a period of 3 hours.
Ankle Joint Moment
Measured through on-board sensors (force sensor and ankle encoder) expressed in Newton*meter.
Measured: Through study completion, a period of 3 hours.
Ankle Joint Power
Measured through on-board sensors (force sensor and ankle encoder) expressed in Watt.
Measured: Through study completion, a period of 3 hours.
Shock absorption
Measure of the shock absorption using data from Inertial Measurement Units (IMU) sensors. The measurement is expressed as a continuous value in multiples of g (g = gravitational force).
Measured: Through study completion, a period of 3 hours.
Multi-axial movement
Movement of the prosthetic ankle in the sagittal, coronal and transverse plane, measured in degrees with respect to its rest position. Measured via on-board Inertial Measurement Units (IMU) and ankle encoder.
Measured: Through study completion, a period of 3 hours.
Attentional demand
Dual-task L-test: functional mobility assessment measuring the time taken to walk 20 meters in an L-shaped path, while simultaneously performing a cognitive task (e.g. subtractions).
Measured: Through study completion, a period of 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lower-Limb AmputationStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530601
- Sponsor's protocol ID
- CIV-25-10-054755
- Acronym
- MAP-CSB
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.
PubMed 24925671General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.
PubMed 25951678Shepherd MK, Simon AM, Zisk J, Hargrove LJ. Patient-Preferred Prosthetic Ankle-Foot Alignment for Ramps and Level-Ground Walking. IEEE Trans Neural Syst Rehabil Eng. 2021;29:52-59. doi: 10.1109/TNSRE.2020.3033711. Epub 2021 Feb 25.
PubMed 33104504Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation in lower limb amputees. Gait Posture. 2007 Feb;25(2):267-78. doi: 10.1016/j.gaitpost.2006.04.008. Epub 2006 May 24.
PubMed 16725325Omana H, Madou E, Montero-Odasso M, Payne MW, Viana R, Hunter SW. The effect of dual-task testing on the balance and gait of people with lower limb amputations: A systematic review. PM R. 2023 Jan;15(1):94-128. doi: 10.1002/pmrj.12702. Epub 2021 Nov 13.
PubMed 34464018Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.
PubMed 39630588Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 1998 Aug;79(8):931-8. doi: 10.1016/s0003-9993(98)90090-9.
PubMed 9710165Lathouwers E, Ampe T, Diaz MA, Meeusen R, De Pauw K. Evaluation of an articulated passive ankle-foot prosthesis. Biomed Eng Online. 2022 Apr 27;21(1):28. doi: 10.1186/s12938-022-00997-6.
PubMed 35477464Jonkergouw N, Prins MR, Buis AW, van der Wurff P. The Effect of Alignment Changes on Unilateral Transtibial Amputee's Gait: A Systematic Review. PLoS One. 2016 Dec 6;11(12):e0167466. doi: 10.1371/journal.pone.0167466. eCollection 2016.
PubMed 27923050Hunter SW, Frengopoulos C, Holmes J, Viana R, Payne MW. Determining Reliability of a Dual-Task Functional Mobility Protocol for Individuals With Lower Extremity Amputation. Arch Phys Med Rehabil. 2018 Apr;99(4):707-712. doi: 10.1016/j.apmr.2017.12.008. Epub 2018 Jan 6.
PubMed 29317224Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
PubMed 28066528Hahn A, Sreckovic I, Reiter S, Mileusnic M. First results concerning the safety, walking, and satisfaction with an innovative, microprocessor-controlled four-axes prosthetic foot. Prosthet Orthot Int. 2018 Jun;42(3):350-356. doi: 10.1177/0309364617747976. Epub 2018 Feb 5.
PubMed 29400252Demers, L., Weiss-Lambrou, R., & Ska, B. (2002). The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): an overview and recent progress. Technology and disability, 14(3), 101-105.
Bai X, Ewins D, Crocombe AD, Xu W. Kinematic and biomimetic assessment of a hydraulic ankle/foot in level ground and camber walking. PLoS One. 2017 Jul 13;12(7):e0180836. doi: 10.1371/journal.pone.0180836. eCollection 2017.
PubMed 28704428
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of a New Ankle-Foot Prosthesis in Daily Use: User Comfort, Safety, and Biomechanical Performance
- ClinicalTrials.gov ID
- NCT07530601
- Acronym / sponsor ID
- MAP-CSB / CIV-25-10-054755
- Conditions
- Lower-Limb Amputation
- Keywords
- ankle-foot prosthesis, daily-life activities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
Detailed description
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
The primary objective of this clinical investigation is to evaluate the safety, effectiveness, and comfort of the new prosthetic foot, along with user satisfaction and its impact on quality of life during daily-life activities. The study aims to determine whether the prosthetic foot can be safely and effectively integrated into the users' routine mobility, while also providing a comfortable experience that enhances overall well-being. In addition to these primary outcomes, the study will address several secondary objectives to gain a more comprehensive understanding of the device's performance. These include assessing the biomechanical characteristics of walking with the new prosthetic foot, specifically focusing on gait parameters. The investigation also aims to evaluate the device's shock absorption capabilities and its ability to support multi-axial movement, both of which are important for natural and efficient locomotion. Furthermore, the study will explore the attentional demand required when walking with the new prosthetic foot, providing insight into how the device affects mental engagement during ambulation. Lastly, the influence of prosthetic alignment on performance and user experience will be examined to optimize fitting and functionality.
Overall, the new prosthetic foot will be assessed during a variety of daily-life activities, with varying familiarization periods, allowing for a holistic evaluation of the prosthetic foot in realistic and diverse usage conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Articulated Prosthetic Foot | Experimental | Device: New Articulated Prosthetic FootParticipants will be fitted with the new articulated prosthetic foot and follow the protocol |
| Current Prosthetic foot | Active comparator | Device: Current Prosthetic footParticipants will be fitted with their current prosthetic foot and follow the protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 - 80 years
- Gender: Men and Women
- Level of amputation:
- Unilateral / bilateral
- Transtibial / transfemoral / knee disarticulation / hip disarticulation
Key exclusion criteria (2 listed)
- Any neurological disease
- Excessive residual limb pain and wounds
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 |
|---|---|---|
| New Articulated Prosthetic FootParticipants with a lower-limb amputation will participate in experiments with the prosthetic device | Device | New Articulated Prosthetic Foot |
| Current Prosthetic footParticipants with a lower-limb amputation will participate in experiments with the prosthetic device | Device | Current Prosthetic foot |
Primary outcome
Comparative Scales: Comfort, Safety, Fatigue and Pain
Time frame: Through study completion, a period of 3 hours.
Visual Analog Scale (VAS) during different activities: walking on flat ground, walking on slopes, climbing and descending stairs, and walking on uneven terrain. VAS is between 0 and 100. Higher scores indicate higher comfort, safety, fatigue or pain.
Preference questionnaire: 5 points Likert scale
Time frame: Through study completion, a period of 3 hours.
Comparison between the current foot and the new articulated foot in several areas : Mobility \& Functionality, Comfort \& Fit, Stability \& Safety, Mechanical Performance. Likert scale is between 1 and 5, where 1 indicates "Much worse", and 5 indicates "Much better".
User satisfaction questionnaire: 5 points Likert scale
Time frame: Through study completion, a period of 3 hours.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-device). Satisfaction scale is between 1 and 5, where 1 indicates "Not satisfied at all", and 5 indicates "Very satisfied".
9 secondary outcomes
Hill assessment index
Time frame: Through study completion, a period of 3 hours.
Stair assessment index
Time frame: Through study completion, a period of 3 hours.
Ankle Joint angles and angular velocities
Time frame: Through study completion, a period of 3 hours.
Temporal Gait parameters
Time frame: Through study completion, a period of 3 hours.
Ankle Joint Moment
Time frame: Through study completion, a period of 3 hours.
Ankle Joint Power
Time frame: Through study completion, a period of 3 hours.
Shock absorption
Time frame: Through study completion, a period of 3 hours.
Multi-axial movement
Time frame: Through study completion, a period of 3 hours.
Attentional demand
Time frame: Through study completion, a period of 3 hours.
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 Apr 2026.
- Background: PubMed 24925671Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.
- Background: PubMed 25951678General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.
- Background: PubMed 33104504Shepherd MK, Simon AM, Zisk J, Hargrove LJ. Patient-Preferred Prosthetic Ankle-Foot Alignment for Ramps and Level-Ground Walking. IEEE Trans Neural Syst Rehabil Eng. 2021;29:52-59. doi: 10.1109/TNSRE.2020.3033711. Epub 2021 Feb 25.
- Background: PubMed 16725325Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation in lower limb amputees. Gait Posture. 2007 Feb;25(2):267-78. doi: 10.1016/j.gaitpost.2006.04.008. Epub 2006 May 24.
- Background: PubMed 34464018Omana H, Madou E, Montero-Odasso M, Payne MW, Viana R, Hunter SW. The effect of dual-task testing on the balance and gait of people with lower limb amputations: A systematic review. PM R. 2023 Jan;15(1):94-128. doi: 10.1002/pmrj.12702. Epub 2021 Nov 13.
- Background: PubMed 39630588Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.
- Background: PubMed 9710165Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 1998 Aug;79(8):931-8. doi: 10.1016/s0003-9993(98)90090-9.
- Background: PubMed 35477464Lathouwers E, Ampe T, Diaz MA, Meeusen R, De Pauw K. Evaluation of an articulated passive ankle-foot prosthesis. Biomed Eng Online. 2022 Apr 27;21(1):28. doi: 10.1186/s12938-022-00997-6.
- Background: PubMed 27923050Jonkergouw N, Prins MR, Buis AW, van der Wurff P. The Effect of Alignment Changes on Unilateral Transtibial Amputee's Gait: A Systematic Review. PLoS One. 2016 Dec 6;11(12):e0167466. doi: 10.1371/journal.pone.0167466. eCollection 2016.
- Background: PubMed 29317224Hunter SW, Frengopoulos C, Holmes J, Viana R, Payne MW. Determining Reliability of a Dual-Task Functional Mobility Protocol for Individuals With Lower Extremity Amputation. Arch Phys Med Rehabil. 2018 Apr;99(4):707-712. doi: 10.1016/j.apmr.2017.12.008. Epub 2018 Jan 6.
- Background: PubMed 28066528Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
- Background: PubMed 29400252Hahn A, Sreckovic I, Reiter S, Mileusnic M. First results concerning the safety, walking, and satisfaction with an innovative, microprocessor-controlled four-axes prosthetic foot. Prosthet Orthot Int. 2018 Jun;42(3):350-356. doi: 10.1177/0309364617747976. Epub 2018 Feb 5.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Articulated Prosthetic Foot and Current Prosthetic foot in people with Lower-Limb Amputation, run by Vrije Universiteit Brussel at 2 sites in Belgium.
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 2 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Contact Kevin De Pauw (475 67 82 64 ext. +32, kevin.de.pauw@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Scales: Comfort, Safety, Fatigue and Pain (time frame: Through study completion, a period of 3 hours.). The study lists 3 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 NCT07530601, which also lists 14 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 15 Apr 2026.