Cognitive ImpairmentNCT07760545
Reliability In Neurocognitive Telemedicine Screening (RING)
An observational study of Cognitive Impairment and Preoperative Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
Trial summary
Perioperative neurocognitive disorders are common after surgery and pre-existing cognitive impairment is an important risk factor. Current guidelines recommend identifying cognitive impairment before surgery; however, screening remains inconsistent, particularly when preoperative assessments are performed remotely. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Preoperative Cognitive Impairment, Perioperative Neurocognitive Disorders
- What is being tested?
- Modified Mini-Cog Telephone Assessment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2023to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will include adults aged 65 years and older who are scheduled for elective surgery and undergoing preoperative anesthetic assessment at Vancouver General Hospital or University of British Columbia Hospital. Participants will be recruited from the Pre-Admission Clinic referral list and will complete a modified Mini-Cog cognitive screening assessment by telephone followed by a standard in-person Mini-Cog assessment during their preoperative visit. The study population represents older adults undergoing surgical evaluation who do not have a known diagnosis of cognitive impairment.
Who may be able to join
- Patients with age >65 at time of listing for pre-operative assessment.
- Patients with a conversational understanding of English language.
- Patients scheduled for in-person consult with an anaesthesiologist.
- Patients awaiting surgery at Vancouver General Hospital or University of British Columbia Hospital.
Who cannot join
- 1. Patients with known cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, BC V5Z 1M9
Stewart Brown, MD, stewart.brown@vch.ca
Shirley Lim, BSN, BS-HRIM, 800-604-875-4111 ext. 66378
About this study
Perioperative neurocognitive disorders are common after surgery and pre-existing cognitive impairment is an important risk factor. Current guidelines recommend identifying cognitive impairment before surgery; however, screening remains inconsistent, particularly when preoperative assessments are performed remotely.
This prospective observational diagnostic validation study aims to determine whether a modified Mini-Cog cognitive screening tool administered by telephone can reliably identify cognitive impairment in patients aged 65 years and older undergoing preoperative assessment. Telephone-based modified Mini-Cog results will be compared with standard in-person Mini-Cog assessments to evaluate agreement and feasibility. This study may improve access to preoperative cognitive screening and support optimization of surgical care for older adults.
Read the detailed description
Perioperative neurocognitive disorders (PND) are common and associated with significant morbidity and economic costs. One of the dominant risk factors for PND is pre-existing cognitive impairment (CI). The importance of detecting CI pre-operatively to facilitate patient selection for optimisation pathways and informed risk assessments is stressed in recent joint guidelines by the American College of Surgeons and the American Geriatrics Society.
Despite these recommendations, screening for pre-operative CI is inconsistently performed. One systematic barrier to CI screening is telemedicine, the use of which has recently seen an inflection point partly precipitated by the Coronavirus pandemic. Telemedicine enables the delivery of tertiary level patient-centred care over expanding geographical catchments, and is likely here to stay.
To date, no brief CI screening tool has been validated for perioperative use via telemedicine.
The Mini-Cog is a brief CI screening tool that is uniquely familiar to perioperative healthcare providers. It is validated in preoperative patients and performs favourably compared to other screening tools in the detection of CI. A Mini-Cog result consistent with CI is strongly associated with postoperative delirium, and is widely used as a trigger for geriatric optimization referral.
Validation of the Mini-Cog delivered via telemedicine is an important step towards improving patient access to CI screening.
Although video pre-operative assessments have been shown to promote high levels of patient and anesthesiologist satisfaction6, it is our local experience that video call technology is less frequently available to older patients, can pose operational challenges for either participant, and reduces workflow flexibility.
Clock Drawing Test (CDT) is an integral part of the Mini-Cog, testing multiple domains of executive function and motor skills, and functioning as a 'distractor' between the registration and recall of three items.
A modified Mini-Cog has been used with illiterate patients unable to use an analogue clock. The CDT was replaced with a serial subtraction task (SST) as an alternate distractor. One study found the modified Mini-Cog correlates with a proxy-rated CI screening tool similarly to the standard Mini-Cog.
Whilst it not feasible to perform a Mini-Cog assessment during a telephone interview, the modified Mini-Cog is an attractive alternative. We therefore aim to validate the modified Mini-Cog assessment for use over the telephone.
Our study involves comparing the validated Mini-Cog with the modified Mini-Cog. Patients awaiting surgery performed the Modified-Mini-Cog with telemedicine and on a later date subsequently performed the validated standard Mini-Cog. We plan to analyse the concordance of the results.
- Conditions
- Cognitive Impairment, Preoperative Cognitive Impairment, Perioperative Neurocognitive Disorders, Neurocognitive Function, Cognitive Screening
- Being tested
- Modified Mini-Cog Telephone Assessment
- Keywords
- Perioperative neurocognitive disorders, Cognitive impairment, Preoperative cognitive screening, Cognitive assessment, Mini-Cog, Modified Mini-Cog, Telephone-based cognitive screening, Telemedicine
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Mini-Cog Telephone AssessmentDiagnostic test
A modified Mini-Cog cognitive screening assessment administered by telephone to evaluate its reliability and concordance with standard in-person Mini-Cog assessment in older adults undergoing preoperative assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between telephone-administered modified Mini-Cog and standard in-person Mini-Cog assessment
Agreement between modified Mini-Cog scores obtained by telephone and standard in-person Mini-Cog scores in identifying cognitive impairment using the established Mini-Cog cutoff score.
Measured: Within 1-2 weeks of telephone assessment
Secondary outcomes (3)
Sensitivity and specificity of telephone modified Mini-Cog
Sensitivity and specificity of the telephone-administered modified Mini-Cog for detection of cognitive impairment compared with the in-person Mini-Cog assessment.
Measured: Within 1-2 weeks of telephone assessment
Completion time of modified Mini-Cog assessment
Time required to complete the telephone and in-person Mini-Cog assessments.
Measured: During each assessment
Feasibility of telephone-based cognitive screening
Proportion of participants able to complete the telephone-administered modified Mini-Cog assessment.
Measured: During telephone assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start2 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver General Hospital
- Responsible party
- Principal investigator, Donald J Young, MD, FRCPC, University of British Columbia
- Investigators
- Stewart Brown, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760545
- Sponsor's protocol ID
- H22-03455
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data will be stored securely and access will be limited to authorized study personnel in accordance with institutional policies and ethical requirements.
Publications
R Core Team (2022). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.
Rotondi MA (2018). _kappaSize: Sample Size Estimation Functions for Studies of Interobserver Agreement_. R package version 1.2, <https://CRAN.R-project.org/package=kappaSize>.
Graham JE, Rockwood K, Beattie BL, Eastwood R, Gauthier S, Tuokko H, McDowell I. Prevalence and severity of cognitive impairment with and without dementia in an elderly population. Lancet. 1997 Jun 21;349(9068):1793-6. doi: 10.1016/S0140-6736(97)01007-6.
PubMed 9269213Donner A, Rotondi MA. Sample size requirements for interval estimation of the kappa statistic for interobserver agreement studies with a binary outcome and multiple raters. Int J Biostat. 2010;6(1):Article 31. doi: 10.2202/1557-4679.1275.
PubMed 21969984Rezaei M, Rashedi V, Lotfi G, Shirinbayan P, Foroughan M. Psychometric Properties of the Persian Adaptation of Mini-Cog Test in Iranian Older Adults. Int J Aging Hum Dev. 2018 Apr;86(3):266-280. doi: 10.1177/0091415017724547. Epub 2017 Aug 31.
PubMed 28859488Tiwary N, Treggiari MM, Yanez ND, Kirsch JR, Tekkali P, Taylor CC, Schenning KJ. Agreement Between the Mini-Cog in the Preoperative Clinic and on the Day of Surgery and Association With Postanesthesia Care Unit Delirium: A Cohort Study of Cognitive Screening in Older Adults. Anesth Analg. 2021 Apr 1;132(4):1112-1119. doi: 10.1213/ANE.0000000000005197.
PubMed 33002933Adhikari SP, Dev R, Borson S. Modifying the Mini-Cog to Screen for Cognitive Impairment in Nonliterate Individuals. Int J Alzheimers Dis. 2021 Aug 16;2021:5510093. doi: 10.1155/2021/5510093. eCollection 2021.
PubMed 34447592Wong DT, Kamming D, Salenieks ME, Go K, Kohm C, Chung F. Preadmission anesthesia consultation using telemedicine technology: a pilot study. Anesthesiology. 2004 Jun;100(6):1605-7. doi: 10.1097/00000542-200406000-00038. No abstract available.
PubMed 15166585Culley DJ, Flaherty D, Fahey MC, Rudolph JL, Javedan H, Huang CC, Wright J, Bader AM, Hyman BT, Blacker D, Crosby G. Poor Performance on a Preoperative Cognitive Screening Test Predicts Postoperative Complications in Older Orthopedic Surgical Patients. Anesthesiology. 2017 Nov;127(5):765-774. doi: 10.1097/ALN.0000000000001859.
PubMed 28891828Decker J, Kaloostian CL, Gurvich T, Nguyen P, Widjaja W, Cardona H, Pagan V, Motamed A, Peden CJ. Beyond Cognitive Screening: Establishing an Interprofessional Perioperative Brain Health Initiative. J Am Geriatr Soc. 2020 Oct;68(10):2359-2364. doi: 10.1111/jgs.16720. Epub 2020 Aug 3.
PubMed 32748487Long LS, Shapiro WA, Leung JM. A brief review of practical preoperative cognitive screening tools. Can J Anaesth. 2012 Aug;59(8):798-804. doi: 10.1007/s12630-012-9737-1. Epub 2012 May 26.
PubMed 22638676Mohanty S, Rosenthal RA, Russell MM, Neuman MD, Ko CY, Esnaola NF. Optimal Perioperative Management of the Geriatric Patient: A Best Practices Guideline from the American College of Surgeons NSQIP and the American Geriatrics Society. J Am Coll Surg. 2016 May;222(5):930-47. doi: 10.1016/j.jamcollsurg.2015.12.026. Epub 2016 Jan 4. No abstract available.
PubMed 27049783Dworkin A, Lee DS, An AR, Goodlin SJ. A Simple Tool to Predict Development of Delirium After Elective Surgery. J Am Geriatr Soc. 2016 Nov;64(11):e149-e153. doi: 10.1111/jgs.14428. Epub 2016 Sep 21.
PubMed 27650453
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability In Neurocognitive Telemedicine Screening (RING)
- ClinicalTrials.gov ID
- NCT07760545
- Acronym / sponsor ID
- H22-03455
- Conditions
- Cognitive Impairment, Preoperative Cognitive Impairment, Perioperative Neurocognitive Disorders, Neurocognitive Function, Cognitive Screening
- Keywords
- Perioperative neurocognitive disorders, Cognitive impairment, Preoperative cognitive screening, Cognitive assessment, Mini-Cog, Modified Mini-Cog, Telephone-based cognitive screening, Telemedicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver General Hospital
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Aug 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.
Perioperative neurocognitive disorders are common after surgery and pre-existing cognitive impairment is an important risk factor. Current guidelines recommend identifying cognitive impairment before surgery; however, screening remains inconsistent, particularly when preoperative assessments are performed remotely.
This prospective observational diagnostic validation study aims to determine whether a modified Mini-Cog cognitive screening tool administered by telephone can reliably identify cognitive impairment in patients aged 65 years and older undergoing preoperative assessment. Telephone-based modified Mini-Cog results will be compared with standard in-person Mini-Cog assessments to evaluate agreement and feasibility. This study may improve access to preoperative cognitive screening and support optimization of surgical care for older adults.
Detailed description
Perioperative neurocognitive disorders (PND) are common and associated with significant morbidity and economic costs. One of the dominant risk factors for PND is pre-existing cognitive impairment (CI). The importance of detecting CI pre-operatively to facilitate patient selection for optimisation pathways and informed risk assessments is stressed in recent joint guidelines by the American College of Surgeons and the American Geriatrics Society.
Despite these recommendations, screening for pre-operative CI is inconsistently performed. One systematic barrier to CI screening is telemedicine, the use of which has recently seen an inflection point partly precipitated by the Coronavirus pandemic. Telemedicine enables the delivery of tertiary level patient-centred care over expanding geographical catchments, and is likely here to stay.
To date, no brief CI screening tool has been validated for perioperative use via telemedicine.
The Mini-Cog is a brief CI screening tool that is uniquely familiar to perioperative healthcare providers. It is validated in preoperative patients and performs favourably compared to other screening tools in the detection of CI. A Mini-Cog result consistent with CI is strongly associated with postoperative delirium, and is widely used as a trigger for geriatric optimization referral.
Validation of the Mini-Cog delivered via telemedicine is an important step towards improving patient access to CI screening.
Although video pre-operative assessments have been shown to promote high levels of patient and anesthesiologist satisfaction6, it is our local experience that video call technology is less frequently available to older patients, can pose operational challenges for either participant, and reduces workflow flexibility.
Clock Drawing Test (CDT) is an integral part of the Mini-Cog, testing multiple domains of executive function and motor skills, and functioning as a 'distractor' between the registration and recall of three items.
A modified Mini-Cog has been used with illiterate patients unable to use an analogue clock. The CDT was replaced with a serial subtraction task (SST) as an alternate distractor. One study found the modified Mini-Cog correlates with a proxy-rated CI screening tool similarly to the standard Mini-Cog.
Whilst it not feasible to perform a Mini-Cog assessment during a telephone interview, the modified Mini-Cog is an attractive alternative. We therefore aim to validate the modified Mini-Cog assessment for use over the telephone.
Our study involves comparing the validated Mini-Cog with the modified Mini-Cog. Patients awaiting surgery performed the Modified-Mini-Cog with telemedicine and on a later date subsequently performed the validated standard Mini-Cog. We plan to analyse the concordance of the results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will include adults aged 65 years and older who are scheduled for elective surgery and undergoing preoperative anesthetic assessment at Vancouver General Hospital or University of British Columbia Hospital. Participants will be recruited from the Pre-Admission Clinic referral list and will complete a modified Mini-Cog cognitive screening assessment by telephone followed by a standard in-person Mini-Cog assessment during their preoperative visit. The study population represents older adults undergoing surgical evaluation who do not have a known diagnosis of cognitive impairment.
Key inclusion criteria (4 listed)
- Patients with age >65 at time of listing for pre-operative assessment.
- Patients with a conversational understanding of English language.
- Patients scheduled for in-person consult with an anaesthesiologist.
- Patients awaiting surgery at Vancouver General Hospital or University of British Columbia Hospital.
Key exclusion criteria (1 listed)
- 1. Patients with known cognitive impairment.
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 |
|---|---|---|
| Modified Mini-Cog Telephone AssessmentA modified Mini-Cog cognitive screening assessment administered by telephone to evaluate its reliability and concordance with standard in-person Mini-Cog assessment in older adults undergoing preoperative assessment. | Diagnostic test | – |
Primary outcome
Concordance between telephone-administered modified Mini-Cog and standard in-person Mini-Cog assessment
Time frame: Within 1-2 weeks of telephone assessment
Agreement between modified Mini-Cog scores obtained by telephone and standard in-person Mini-Cog scores in identifying cognitive impairment using the established Mini-Cog cutoff score.
3 secondary outcomes
Sensitivity and specificity of telephone modified Mini-Cog
Time frame: Within 1-2 weeks of telephone assessment
Completion time of modified Mini-Cog assessment
Time frame: During each assessment
Feasibility of telephone-based cognitive screening
Time frame: During telephone assessment
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 12 Aug 2026.
- BackgroundR Core Team (2022). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.
- BackgroundRotondi MA (2018). _kappaSize: Sample Size Estimation Functions for Studies of Interobserver Agreement_. R package version 1.2, <https://CRAN.R-project.org/package=kappaSize>.
- Background: PubMed 9269213Graham JE, Rockwood K, Beattie BL, Eastwood R, Gauthier S, Tuokko H, McDowell I. Prevalence and severity of cognitive impairment with and without dementia in an elderly population. Lancet. 1997 Jun 21;349(9068):1793-6. doi: 10.1016/S0140-6736(97)01007-6.
- Background: PubMed 21969984Donner A, Rotondi MA. Sample size requirements for interval estimation of the kappa statistic for interobserver agreement studies with a binary outcome and multiple raters. Int J Biostat. 2010;6(1):Article 31. doi: 10.2202/1557-4679.1275.
- Background: PubMed 28859488Rezaei M, Rashedi V, Lotfi G, Shirinbayan P, Foroughan M. Psychometric Properties of the Persian Adaptation of Mini-Cog Test in Iranian Older Adults. Int J Aging Hum Dev. 2018 Apr;86(3):266-280. doi: 10.1177/0091415017724547. Epub 2017 Aug 31.
- Background: PubMed 33002933Tiwary N, Treggiari MM, Yanez ND, Kirsch JR, Tekkali P, Taylor CC, Schenning KJ. Agreement Between the Mini-Cog in the Preoperative Clinic and on the Day of Surgery and Association With Postanesthesia Care Unit Delirium: A Cohort Study of Cognitive Screening in Older Adults. Anesth Analg. 2021 Apr 1;132(4):1112-1119. doi: 10.1213/ANE.0000000000005197.
- Background: PubMed 34447592Adhikari SP, Dev R, Borson S. Modifying the Mini-Cog to Screen for Cognitive Impairment in Nonliterate Individuals. Int J Alzheimers Dis. 2021 Aug 16;2021:5510093. doi: 10.1155/2021/5510093. eCollection 2021.
- Background: PubMed 15166585Wong DT, Kamming D, Salenieks ME, Go K, Kohm C, Chung F. Preadmission anesthesia consultation using telemedicine technology: a pilot study. Anesthesiology. 2004 Jun;100(6):1605-7. doi: 10.1097/00000542-200406000-00038. No abstract available.
- Background: PubMed 28891828Culley DJ, Flaherty D, Fahey MC, Rudolph JL, Javedan H, Huang CC, Wright J, Bader AM, Hyman BT, Blacker D, Crosby G. Poor Performance on a Preoperative Cognitive Screening Test Predicts Postoperative Complications in Older Orthopedic Surgical Patients. Anesthesiology. 2017 Nov;127(5):765-774. doi: 10.1097/ALN.0000000000001859.
- Background: PubMed 32748487Decker J, Kaloostian CL, Gurvich T, Nguyen P, Widjaja W, Cardona H, Pagan V, Motamed A, Peden CJ. Beyond Cognitive Screening: Establishing an Interprofessional Perioperative Brain Health Initiative. J Am Geriatr Soc. 2020 Oct;68(10):2359-2364. doi: 10.1111/jgs.16720. Epub 2020 Aug 3.
- Background: PubMed 22638676Long LS, Shapiro WA, Leung JM. A brief review of practical preoperative cognitive screening tools. Can J Anaesth. 2012 Aug;59(8):798-804. doi: 10.1007/s12630-012-9737-1. Epub 2012 May 26.
- Background: PubMed 27049783Mohanty S, Rosenthal RA, Russell MM, Neuman MD, Ko CY, Esnaola NF. Optimal Perioperative Management of the Geriatric Patient: A Best Practices Guideline from the American College of Surgeons NSQIP and the American Geriatrics Society. J Am Coll Surg. 2016 May;222(5):930-47. doi: 10.1016/j.jamcollsurg.2015.12.026. Epub 2016 Jan 4. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data will be stored securely and access will be limited to authorized study personnel in accordance with institutional policies and ethical requirements.
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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.
Stewart Brown, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Preoperative Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 1 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 12 Aug 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 Canada. 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 Donald Young, MD (800-604-875-4304 ext. 54304, donald.young@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between telephone-administered modified Mini-Cog and standard in-person Mini-Cog assessment (time frame: Within 1-2 weeks of telephone assessment). 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 NCT07760545, which also lists 13 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 12 Aug 2026.