Sickle Cell DiseaseNCT06773715
Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain
A study testing KindVR Aqua Program in people with Sickle Cell Disease and Vaso-occlusive Pain Episodes, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are: Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis? Does virtual reality decrease the… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Pain Episodes
- What is being tested?
- KindVR Aqua Program
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to 19 Dec 2025
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient ≥ 8 up to 21 years of age
- Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management
- No known cognitive or neurological deficits
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Patients aged 7-years-old and younger.
- Patents upon admission found to have sequela of their sickle cell disease that would require medical therapy greater than the standard of care for a vaso-occlusive pain event. This includes acute chest syndrome, splenic sequestration, post-operative pain, and/or cerebrovascular accident
- Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately
- Failure to obtain or refusal to provide parental/guardian permission (informed consent) and if appropriate child assent
- Patient has previously participated in the study
- Study team is unable to initiate study interventions within the first 24 hours of a patient's admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Molly E Sonenklar, MD, 504-896-9740, msonen@lsuhsc.edu
Casey M Treuting, MD, 504-273-3476, ctreu1@lsuhsc.edu
About this study
Official title: Changing the View of Pain: Using Virtual Reality As Adjunctive Therapy for Sickle Cell Pain in Pediatric Patients
The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are:
Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis?
Read more
Does virtual reality decrease the daily use of opiates?
Researchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain.
All patients will:
- Be asked to fill out a pain assessment survey three times daily for up to 3 days
If randomized to intervention arm, patients will:
- Participate in an immersive virtual reality experience once daily for up to 3 days
- Fill out a survey twice daily to monitor for side effects from virtual reality experience
- Fill out a satisfaction survey once during the study period
Read the detailed description
A vaso-occlusive pain crisis is the most common complaint for which a patient with sickle cell disease requires admission to the hospital. These pain episodes can often be complex and difficult to manage as medical providers know each individual patient perceives pain differently. In this regard, it has been well studied that a multi-disciplinary approach is required to address the biological, psychological, and social factors that comprise a patient's experienced pain. The current standard therapy for vaso-occlusive pain is heavily reliant on opioid therapy, which is why efforts have been made to find other complementary therapies with intentions of reducing this need. By conducting this study, the investigators hope to show that virtual reality can not only provide a complementary role in addressing sickle cell pain but also enhance patient satisfaction for those who have been admitted to the inpatient unit in a time of need.
The idea of using virtual reality as a complementary therapy to address pain and stress in different types of medical patients has been introduced and explored for the last 10 years. There are a limited number of studies currently being carried out, but since 2014, the KindVR company has partnered with medical institutions across the United States and Canada to study the impacts that virtual reality can have on different pediatric patients. This includes sickle cell patients experiencing a pain crisis, cancer patients undergoing port access, burn patients, and those dealing with stress associated with a procedure or imaging study. A previous study in 2018 displayed the feasibility of administering a virtual reality (VR) experience to patients admitted to the hospital for a sickle cell pain crisis. However, there are no published studies assessing the measurable impacts that the use of VR could have on aspects of patient care. It is well known that a multi-disciplinary approach is the best method to address sickle cell pain. The investigators believe it would be interesting to see if the advanced technology of virtual reality can provide a complementary role to the current standard of care.
To best elicit the results of our treatment intervention, this study will be constructed as a randomized control study. During the screening phase, every patient that is admitted to Children's Hospital of New Orleans for a vaso-occlusive pain episode will first have eligibility for enrollment into the study determined by established inclusion and exclusion criteria. Prior to enrollment, informed consent, patient assent (if applicable), and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained. For the study treatment phase, patients will be assigned to either the control or case group. Control patients will undergo scheduled pain assessments while receiving standard of care therapy for a vaso-occlusive pain crisis. Case patients will undergo scheduled pain assessments while receiving standard of care therapy in addition to participating in a daily immersive VR experience during admission for a vaso-occlusive pain crisis. Both groups of patients will concurrently be in the hospital at the same time. All patients will participate in the study for a maximum of 3 days while enrolled on study and remain admitted requiring further treatment for vaso-occlusive pain. There will be no follow-up phase as a part of this study.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episodes
- Being tested
- KindVR Aqua Program
- Keywords
- virtual reality, adjunctive therapy, opiate consumption, pain reduction
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KindVR Aqua ProgramDevice
For this study, patients will be introduced to a virtual reality software program called Aqua, created by the company KindVR. This software program was designed specifically for use in pediatric patients. The software has been programmed into the Pico Neo 3 headset and provides an immersive 3D experience during which the patients explore a virtual underwater world inside a submarine with a goal of providing more color to treasure and different sea animals that they will engage with along their journey. The VR experience itself lasts approximately 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission |
| Cases | Experimental | In addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire. Receives: Device: KindVR Aqua Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The Adolescent-Pediatric Pain Tool is a well validated, multidimensional pain assessment tool designed to evaluate the location, severity, and quality of pain in pediatric patients. It is comprised of three independent parts, one which is a 10 cm line anchored from 0 to10, with zero being equivalent to "no pain" and 10 being equivalent to "worst pain possible". This data point will be collected up to 9 times for each participant in this study. The trends will be compared amongst the control and case groups.
Measured: From enrollment to the end of hospital admission day 3.
Secondary outcomes (3)
Opiate Consumption
Goal is to assess virtual reality's ability to decrease a patient's total opiate consumption during their inpatient admission. Equivalent opiate dosing per day, measured in oral morphine equivalents/kg/day for each participant.
Measured: From enrollment to the end of hospital admission day 3.
Hospital Length of Stay.
Assessing whether the use of virtual reality for a patient's vaso-occlusive pain crisis can reduce their length of stay in the hospital. Measured in number of days.
Measured: From enrollment to hospital discharge (an average of 5 days)
Patient Satisfaction (for case patients only)
The study will evaluate whether the use of virtual reality's ability to improve patient satisfaction for their hospital admission. This will be measured via the use of the Post-Study Questionnaire, a 16-question survey provided by the KindVR company. It will be used to assess the patient's satisfaction of the Aqua program, the comfort of the equipment, and future guidance to aid quality improvement.
Measured: Once, on day 2 or day 3 of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start12 Sep 2024
- Primary completion19 Dec 2025 (estimated)
- Study completion19 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study * Control patients will receive standard of care therapy for their vaso-occlusive pain crisis * Case patients will receive standard of care therapy PLUS VR experience for their vaso-occlusive pain crisis * Patients will be randomly assigned into the case or control group based off a random number system that will assign N/2 patients into each group. The statistician included on this project will generate the random numbers prior to the enrollment of the first patient onto the study. * To ensure equality between case and control groups, block stratification based on age and gender will be utilized at the time of data analysis
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- KindVR
- Responsible party
- Principal investigator, Molly Sonenklar, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773715
- Sponsor's protocol ID
- IRB# 7634
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litwin SP, Nguyen C, Hundert A, Stuart S, Liu D, Maguire B, Matava C, Stinson J. Virtual Reality to Reduce Procedural Pain During IV Insertion in the Pediatric Emergency Department: A Pilot Randomized Controlled Trial. Clin J Pain. 2021 Feb 1;37(2):94-101. doi: 10.1097/AJP.0000000000000894.
PubMed 33177370Fernandes AM, De Campos C, Batalha L, Perdigao A, Jacob E. Pain assessment using the adolescent pediatric pain tool: a systematic review. Pain Res Manag. 2014 Jul-Aug;19(4):212-8. doi: 10.1155/2014/979416. Epub 2014 Jun 20.
PubMed 24950413Birnie KA, Kulandaivelu Y, Jibb L, Hroch P, Positano K, Robertson S, Campbell F, Abla O, Stinson J. Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text]. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):406-416. doi: 10.1177/1043454218782138. Epub 2018 Jun 27.
PubMed 29950139Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
PubMed 15745448Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.
PubMed 30362236
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the View of Pain: Using Virtual Reality As Adjunctive Therapy for Sickle Cell Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06773715
- Acronym / sponsor ID
- IRB# 7634
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episodes
- Keywords
- virtual reality, adjunctive therapy, opiate consumption, pain reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- KindVR
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 19 Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are:
Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis?
Does virtual reality decrease the daily use of opiates?
Researchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain.
All patients will:
- Be asked to fill out a pain assessment survey three times daily for up to 3 days
If randomized to intervention arm, patients will:
- Participate in an immersive virtual reality experience once daily for up to 3 days
- Fill out a survey twice daily to monitor for side effects from virtual reality experience
- Fill out a satisfaction survey once during the study period
Detailed description
A vaso-occlusive pain crisis is the most common complaint for which a patient with sickle cell disease requires admission to the hospital. These pain episodes can often be complex and difficult to manage as medical providers know each individual patient perceives pain differently. In this regard, it has been well studied that a multi-disciplinary approach is required to address the biological, psychological, and social factors that comprise a patient's experienced pain. The current standard therapy for vaso-occlusive pain is heavily reliant on opioid therapy, which is why efforts have been made to find other complementary therapies with intentions of reducing this need. By conducting this study, the investigators hope to show that virtual reality can not only provide a complementary role in addressing sickle cell pain but also enhance patient satisfaction for those who have been admitted to the inpatient unit in a time of need.
The idea of using virtual reality as a complementary therapy to address pain and stress in different types of medical patients has been introduced and explored for the last 10 years. There are a limited number of studies currently being carried out, but since 2014, the KindVR company has partnered with medical institutions across the United States and Canada to study the impacts that virtual reality can have on different pediatric patients. This includes sickle cell patients experiencing a pain crisis, cancer patients undergoing port access, burn patients, and those dealing with stress associated with a procedure or imaging study. A previous study in 2018 displayed the feasibility of administering a virtual reality (VR) experience to patients admitted to the hospital for a sickle cell pain crisis. However, there are no published studies assessing the measurable impacts that the use of VR could have on aspects of patient care. It is well known that a multi-disciplinary approach is the best method to address sickle cell pain. The investigators believe it would be interesting to see if the advanced technology of virtual reality can provide a complementary role to the current standard of care.
To best elicit the results of our treatment intervention, this study will be constructed as a randomized control study. During the screening phase, every patient that is admitted to Children's Hospital of New Orleans for a vaso-occlusive pain episode will first have eligibility for enrollment into the study determined by established inclusion and exclusion criteria. Prior to enrollment, informed consent, patient assent (if applicable), and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained. For the study treatment phase, patients will be assigned to either the control or case group. Control patients will undergo scheduled pain assessments while receiving standard of care therapy for a vaso-occlusive pain crisis. Case patients will undergo scheduled pain assessments while receiving standard of care therapy in addition to participating in a daily immersive VR experience during admission for a vaso-occlusive pain crisis. Both groups of patients will concurrently be in the hospital at the same time. All patients will participate in the study for a maximum of 3 days while enrolled on study and remain admitted requiring further treatment for vaso-occlusive pain. There will be no follow-up phase as a part of this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study * Control patients will receive standard of care therapy for their vaso-occlusive pain crisis * Case patients will receive standard of care therapy PLUS VR experience for their vaso-occlusive pain crisis * Patients will be randomly assigned into the case or control group based off a random number system that will assign N/2 patients into each group. The statistician included on this project will generate the random numbers prior to the enrollment of the first patient onto the study. * To ensure equality between case and control groups, block stratification based on age and gender will be utilized at the time of data analysis
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission |
| Cases | Experimental | Device: KindVR Aqua ProgramIn addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient ≥ 8 up to 21 years of age
- Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management
- No known cognitive or neurological deficits
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Key exclusion criteria (6 listed)
- Patients aged 7-years-old and younger.
- Patents upon admission found to have sequela of their sickle cell disease that would require medical therapy greater than the standard of care for a vaso-occlusive pain event. This includes acute chest syndrome, splenic sequestration, post-operative pain, and/or cerebrovascular accident
- Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately
- Failure to obtain or refusal to provide parental/guardian permission (informed consent) and if appropriate child assent
- Patient has previously participated in the study
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 |
|---|---|---|
| KindVR Aqua ProgramFor this study, patients will be introduced to a virtual reality software program called Aqua, created by the company KindVR. This software program was designed specifically for use in pediatric patients. The software has been programmed into the Pico Neo 3 headset and provides an immersive 3D experience during which the patients explore a virtual underwater world inside a submarine with a goal of providing more color to treasure and different sea animals that they will engage with along their journey. The VR experience itself lasts approximately 15 minutes | Device | Cases |
Primary outcome
Pain severity
Time frame: From enrollment to the end of hospital admission day 3.
The Adolescent-Pediatric Pain Tool is a well validated, multidimensional pain assessment tool designed to evaluate the location, severity, and quality of pain in pediatric patients. It is comprised of three independent parts, one which is a 10 cm line anchored from 0 to10, with zero being equivalent to "no pain" and 10 being equivalent to "worst pain possible". This data point will be collected up to 9 times for each participant in this study. The trends will be compared amongst the control and case groups.
3 secondary outcomes
Opiate Consumption
Time frame: From enrollment to the end of hospital admission day 3.
Hospital Length of Stay.
Time frame: From enrollment to hospital discharge (an average of 5 days)
Patient Satisfaction (for case patients only)
Time frame: Once, on day 2 or day 3 of enrollment
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 14 Jan 2025.
- Background: PubMed 33177370Litwin SP, Nguyen C, Hundert A, Stuart S, Liu D, Maguire B, Matava C, Stinson J. Virtual Reality to Reduce Procedural Pain During IV Insertion in the Pediatric Emergency Department: A Pilot Randomized Controlled Trial. Clin J Pain. 2021 Feb 1;37(2):94-101. doi: 10.1097/AJP.0000000000000894.
- Background: PubMed 24950413Fernandes AM, De Campos C, Batalha L, Perdigao A, Jacob E. Pain assessment using the adolescent pediatric pain tool: a systematic review. Pain Res Manag. 2014 Jul-Aug;19(4):212-8. doi: 10.1155/2014/979416. Epub 2014 Jun 20.
- Background: PubMed 29950139Birnie KA, Kulandaivelu Y, Jibb L, Hroch P, Positano K, Robertson S, Campbell F, Abla O, Stinson J. Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text]. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):406-416. doi: 10.1177/1043454218782138. Epub 2018 Jun 27.
- Background: PubMed 15745448Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
- Background: PubMed 30362236Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KindVR Aqua Program in people with Sickle Cell Disease and Vaso-occlusive Pain Episodes, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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 6 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Molly E Sonenklar, MD (504-896-9740, msonen@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: From enrollment to the end of hospital admission day 3.). 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 NCT06773715, 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 14 Jan 2025.