Athletes With Previous Lateral Ankle Sprain(s)NCT03311490
The Spraino Pilot Trial
A study testing Spraino in people with Athletes With Previous Lateral Ankle Sprain(s), run by Spraino at 2 sites in Denmark.
Trial summary
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletes With Previous Lateral Ankle Sprain(s)
- What is being tested?
- Spraino
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 2 sitesDenmark
- Study dates
- 19 Oct 2017to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is ≥ 18 years old at commencement of trial.
- Participant can read, speak and understand Danish.
- Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
- Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
- Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
- Participant has returned to play at commencement of the trial.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
Aalborg, 9220
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
Hvidovre, 2650
About this study
Official title: A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.
All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.
Read the detailed description
The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.
It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).
It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.
A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.
Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.
- Being tested
- Spraino
- Keywords
- Ankle Sprain, Prophylaxis, Indoor Sports, Ligamentous sprain, Prevention
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SprainoDevice
Participants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or "Teflon") patch. It is developed with the intent of minimizing lateral shoe- surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains. Receives: Device: Spraino |
| Control | No intervention | Participants allocated to the control group will be a "do-as-usual" comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral ankle sprains
Rate of lateral ankle sprains (continuous)
The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure.
Measured: 52 weeks
First-time non-contact lateral ankle sprains
Rate of first-time non-contact lateral ankle sprains (continuous)
The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure.
Measured: 52 weeks
Time-loss due to first-time non-contact lateral ankle sprains
Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous)
Measured: 52 weeks
Severe first-time non-contact lateral ankle sprains
Rate of severe first-time non-contact lateral ankle sprains (continuous)
The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Measured: 52 weeks
Recurrent non-contact lateral ankle sprains
Rate of recurrent non-contact lateral ankle sprains (continuous)
The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure.
Measured: 52 weeks
Time-loss due to recurrent non-contact lateral ankle sprains
Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous)
Measured: 52 weeks
Severe recurrent non-contact lateral ankle sprains
Rate of severe recurrent non-contact lateral ankle sprains (continuous)
The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Measured: 52 weeks
First-time lateral ankle sprains
Rate of first-time lateral ankle sprains (continuous)
The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure.
Measured: 52 weeks
Time-loss due to first-time lateral ankle sprains
Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous)
Measured: 52 weeks
Severe first-time lateral ankle sprains
Rate of severe first-time lateral ankle sprains (continuous)
The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Measured: 52 weeks
Recurrent lateral ankle sprains
Rate of recurrent lateral ankle sprains (continuous)
The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure.
Measured: 52 weeks
Time-loss due to recurrent lateral ankle sprains
Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous)
Measured: 52 weeks
Severe recurrent lateral ankle sprains
Rate of severe recurrent lateral ankle sprains (continuous)
The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start19 Oct 2017
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: The decision to halt the trial in October was made in June, as the anticipated no. of events(ankle sprains) required for the analyses was almost reached in June
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Athletes With Previous Lateral Ankle Sprain(s)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spraino
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Hvidovre, Aalborg University, Metropolitan University College, The Copenhagen Center for Health Technology (CACHET)
- Responsible party
- Sponsor
- Investigators
- Filip G Lysdal, MSc, Principal investigator, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, DenmarkKristian Thorborg, PhD, Study director, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, DenmarkThomas Q Bandholm, PhD, Study chair, Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, DenmarkEamonn Delahunt, PhD, Study chair, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311490
- Sponsor's protocol ID
- 4559
- Status last verified
- Aug 2019
- First submitted
- 11 Oct 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. No abstract available.
PubMed 28882839Lysdal FG, Bandholm T, Tolstrup JS, Clausen MB, Mann S, Petersen PB, Gronlykke TB, Kersting UG, Delahunt E, Thorborg K. Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. Br J Sports Med. 2021 Jan;55(2):92-98. doi: 10.1136/bjsports-2019-101767. Epub 2020 Aug 12.
PubMed 32796016
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
- ClinicalTrials.gov ID
- NCT03311490
- Acronym / sponsor ID
- 4559
- Keywords
- Ankle Sprain, Prophylaxis, Indoor Sports, Ligamentous sprain, Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to halt the trial in October was made in June, as the anticipated no. of events(ankle sprains) required for the analyses was almost reached in June
- Enrolment
- 510 participants (actual)
- Lead sponsor
- SprainoIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Hvidovre, Aalborg University, Metropolitan University College, The Copenhagen Center for Health Technology (CACHET)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 17 Oct 2017 (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 pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.
All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.
Detailed description
The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.
It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).
It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.
A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.
Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: SprainoParticipants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains. |
| Control | No intervention | –Participants allocated to the control group will be a "do-as-usual" comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is ≥ 18 years old at commencement of trial.
- Participant can read, speak and understand Danish.
- Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
- Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
- Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SprainoParticipants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or "Teflon") patch. It is developed with the intent of minimizing lateral shoe- surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period. | Device | Intervention |
Primary outcome
Lateral ankle sprains
Time frame: 52 weeks
Rate of lateral ankle sprains (continuous) The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure.
First-time non-contact lateral ankle sprains
Time frame: 52 weeks
Rate of first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure.
Time-loss due to first-time non-contact lateral ankle sprains
Time frame: 52 weeks
Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous)
Severe first-time non-contact lateral ankle sprains
Time frame: 52 weeks
Rate of severe first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Recurrent non-contact lateral ankle sprains
Time frame: 52 weeks
Rate of recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure.
Time-loss due to recurrent non-contact lateral ankle sprains
Time frame: 52 weeks
Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous)
Severe recurrent non-contact lateral ankle sprains
Time frame: 52 weeks
Rate of severe recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
First-time lateral ankle sprains
Time frame: 52 weeks
Rate of first-time lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure.
Time-loss due to first-time lateral ankle sprains
Time frame: 52 weeks
Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous)
Severe first-time lateral ankle sprains
Time frame: 52 weeks
Rate of severe first-time lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Recurrent lateral ankle sprains
Time frame: 52 weeks
Rate of recurrent lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure.
Time-loss due to recurrent lateral ankle sprains
Time frame: 52 weeks
Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous)
Severe recurrent lateral ankle sprains
Time frame: 52 weeks
Rate of severe recurrent lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Results and safety
The study was stopped early (reason given: The decision to halt the trial in October was made in June, as the anticipated no. of events(ankle sprains) required for the analyses was almost reached in June). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 28882839Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. No abstract available.
- Derived from this study: PubMed 32796016Lysdal FG, Bandholm T, Tolstrup JS, Clausen MB, Mann S, Petersen PB, Gronlykke TB, Kersting UG, Delahunt E, Thorborg K. Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. Br J Sports Med. 2021 Jan;55(2):92-98. doi: 10.1136/bjsports-2019-101767. Epub 2020 Aug 12.
- Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Filip G Lysdal, MSc principal investigator
Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
Kristian Thorborg, PhD study director
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
Thomas Q Bandholm, PhD study chair
Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spraino in people with Athletes With Previous Lateral Ankle Sprain(s), run by Spraino at 2 sites in Denmark.
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 0 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: stopped early, as of the sponsor's last update on 30 Aug 2019. 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 Denmark. 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?
The study was stopped early (reason given: The decision to halt the trial in October was made in June, as the anticipated no. of events(ankle sprains) required for the analyses was almost reached in June). Results are not available in the source record.
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?
Lateral ankle sprains (time frame: 52 weeks). The study lists 13 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 NCT03311490, which also lists 3 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 30 Aug 2019.