Cerebral StrokePhase 2NCT04149379
Hyperbaric Oxygen Therapy After Stroke - PILOT
A Phase 2 study testing Hyperbaric oxygen in people with Cerebral Stroke, run by Norwegian Underwater Intervention (NUI) at 1 site in Norway.
Trial summary
The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- 20 Apr 2020to 20 Dec 2021
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Claustrophobia
- Psychosis, severe anxiety
- Inability to equalize pressure in the middle ear
- Severe COPD and asthma, pathological lung sounds
- Hypertension (Blood pressure > 140/90 mmHg)
- Pregnancy
Show all 20Show fewer
- Hernia
- Earlier fractures, or suspected fractures in the face
- Ongoing chemotherapy
- Previous treatment with Bleomycin
- Aphasia that prevents necessary communication
- Cognitive failure that prevents necessary co-operation in the pressure chamber.
- Previous or current pneumothorax, other lung injury
- Increased risk of pneumothorax
- Known or suspected injury to the chest
- Marfan syndrome
- Homocystinuria
- Family history of pneumothorax
- Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
- Tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT
The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.
Read the detailed description
This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.
The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).
- Conditions
- Cerebral Stroke
- Being tested
- Hyperbaric oxygen
- Keywords
- Stroke, Hyperbaric oxygen
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90. Receives: Drug: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved physical and cognitive function in activities of daily living.
The project's physiotherapist and ergo therapist from Western Norway University of Applied Sciences (HVL) are responsible for examining physical function and the participant's ability to acquire and use knowledge, as well as function in everyday living activities (ADL). Three measurements are made before starting treatment (establishing a baseline), where the third measurement is done on the same day as treatment starts to eliminate changes in test results as a result of learning the tests. Measurements are also made immediately after the end of treatment, as well as follow-up measurements after 6 and 12 months. Descriptions below.
Measured: 0+6+12 months after end of treatment period
Short Physical Performance Battery (SPPB)
This test is very widely used to provide a quick and validated test of strength, balance and coordination. The test has a roof effect, so it is not suitable for capturing very small and subtle self-perceived disturbances in function. The test is very sensitive to change in the target group.
Measured: 0+6+12 months after end of treatment period
Grip strength
There is a recognized and validated connection between general function and health and grip strength, as well as between grip strength and life span. Grip strength changes as other function changes.
Measured: 0+6+12 months after end of treatment period
Fatigue Severity Scale (FSC)
A major problem after stroke and in many brain disorders is fatigue. Fatigue leads to reduced foxing and thus loss of function. The test is believed to be able to detect changes that are relevant to everyday life function and social participation.
Measured: 0+6+12 months after end of treatment period
Canadian Occupational Performance Measure (COPM)
COPM is designed to help people identify and prioritize activity problems, as well as evaluate activity performance and satisfaction with activity execution. In an interview, the person is asked to describe activities they consider important but find it difficult to perform. Among the aforementioned challenges, the person is asked to prioritize a maximum of five activities he / she wants to be able to perform better after the end of treatment. Then, the person is asked to score the current performance and satisfaction with the current performance of priority activities. The score scale is from 1-10 where 10 indicates very good workmanship or high satisfaction. After the interview, partial scores for execution (COPM-U) and satisfaction (COPM-T) are calculated. A change score of 3 points is considered a clinically important change. COPM has shown good measurement properties, among other things for participants with stroke and the elderly.
Measured: 0+6+12 months after end of treatment period
Action Research Arm Test (ARAT)
ARAT is a tool designed to assess motor function in the arm after stroke. The tasks in the test reflect daily activities and the patient's ability to perform them. The test contains 19 sub-tasks in which different grips (five-finger grips, cylinder grips, tweezers grips), as well as gross motor skills are specifically assessed. In each of the 19 tasks, a score is given from 0-3, where high scores indicate good arm function. The total score (0-57) is the sum of the sub-scores. The test has shown promising measurement properties. For participants in the chronic and subacute phase after stroke, a change of 5.7 points (10%) is considered clinically important. Norwegian guidelines will be used in the study.
Measured: 0+6+12 months after end of treatment period
Nine Hole Peg Test (NHPT)
NHPT is a simple test of fine motor skills that is recommended, among other things, for participants with stroke. Scoring is based on the time the patient spends in placing and removing nine small pieces in nine holes. Total time (maximum 50 seconds) and total number of pins are indicated. The test has shown satisfactory reliability and validity.
Measured: 0+6+12 months after end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start20 Apr 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Why it stopped: Because of the economic consequences of the COVID-19 pandemic 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single subject SSED
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Underwater Intervention (NUI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Western Norway University of Applied Sciences, Helse-Bergen HF
- Responsible party
- Sponsor
- Investigators
- Tobba T Südmann, PhD, Principal investigator, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149379
- Sponsor's protocol ID
- 305476
- Status last verified
- Apr 2020
- First submitted
- 29 Oct 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heyboer M 3rd, Sharma D, Santiago W, McCulloch N. Hyperbaric Oxygen Therapy: Side Effects Defined and Quantified. Adv Wound Care (New Rochelle). 2017 Jun 1;6(6):210-224. doi: 10.1089/wound.2016.0718.
PubMed 28616361Plafki C, Peters P, Almeling M, Welslau W, Busch R. Complications and side effects of hyperbaric oxygen therapy. Aviat Space Environ Med. 2000 Feb;71(2):119-24.
PubMed 10685584Mu J, Ostrowski RP, Soejima Y, Rolland WB, Krafft PR, Tang J, Zhang JH. Delayed hyperbaric oxygen therapy induces cell proliferation through stabilization of cAMP responsive element binding protein in the rat model of MCAo-induced ischemic brain injury. Neurobiol Dis. 2013 Mar;51:133-43. doi: 10.1016/j.nbd.2012.11.003. Epub 2012 Nov 10.
PubMed 23146993Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017 Mar;47(1):24-32. doi: 10.28920/dhm47.1.24-32.
PubMed 28357821Al-Waili NS, Butler GJ, Beale J, Abdullah MS, Hamilton RW, Lee BY, Lucus P, Allen MW, Petrillo RL, Carrey Z, Finkelstein M. Hyperbaric oxygen in the treatment of patients with cerebral stroke, brain trauma, and neurologic disease. Adv Ther. 2005 Nov-Dec;22(6):659-78. doi: 10.1007/BF02849960.
PubMed 16510383Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29.
PubMed 24471697Rosario ER, Kaplan SE, Khonsari S, Vazquez G, Solanki N, Lane M, Brownell H, Rosenberg SS. The Effect of Hyperbaric Oxygen Therapy on Functional Impairments Caused by Ischemic Stroke. Neurol Res Int. 2018 Oct 9;2018:3172679. doi: 10.1155/2018/3172679. eCollection 2018.
PubMed 30402285Wang W, Osenbroch P, Skinnes R, Esbensen Y, Bjoras M, Eide L. Mitochondrial DNA integrity is essential for mitochondrial maturation during differentiation of neural stem cells. Stem Cells. 2010 Dec;28(12):2195-204. doi: 10.1002/stem.542.
PubMed 20954243Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
PubMed 23335971Godman CA, Chheda KP, Hightower LE, Perdrizet G, Shin DG, Giardina C. Hyperbaric oxygen induces a cytoprotective and angiogenic response in human microvascular endothelial cells. Cell Stress Chaperones. 2010 Jul;15(4):431-42. doi: 10.1007/s12192-009-0159-0. Epub 2009 Dec 1.
PubMed 19949909Vila JF, Balcarce PE, Abiusi GR, Dominguez RO, Pisarello JB. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: a prospective single-blind controlled trial. Undersea Hyperb Med. 2005 Sep-Oct;32(5):341-9.
PubMed 16457083
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT
- ClinicalTrials.gov ID
- NCT04149379
- Acronym / sponsor ID
- 305476
- Conditions
- Cerebral Stroke
- Keywords
- Stroke, Hyperbaric oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of the economic consequences of the COVID-19 pandemic 2020
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian Underwater Intervention (NUI)Industry (pharma, biotech, devices)
- Collaborators
- Western Norway University of Applied Sciences, Helse-Bergen HF
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 4 Nov 2019 (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 pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.
Detailed description
This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.
The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single subject SSED
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Hyperbaric oxygenOne group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Claustrophobia
- Psychosis, severe anxiety
- Inability to equalize pressure in the middle ear
- Severe COPD and asthma, pathological lung sounds
- Hypertension (Blood pressure > 140/90 mmHg)
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 |
|---|---|---|
| Hyperbaric oxygen20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90. | Drug | Treatment group |
Primary outcome
Improved physical and cognitive function in activities of daily living.
Time frame: 0+6+12 months after end of treatment period
The project's physiotherapist and ergo therapist from Western Norway University of Applied Sciences (HVL) are responsible for examining physical function and the participant's ability to acquire and use knowledge, as well as function in everyday living activities (ADL). Three measurements are made before starting treatment (establishing a baseline), where the third measurement is done on the same day as treatment starts to eliminate changes in test results as a result of learning the tests. Measurements are also made immediately after the end of treatment, as well as follow-up measurements after 6 and 12 months. Descriptions below.
Short Physical Performance Battery (SPPB)
Time frame: 0+6+12 months after end of treatment period
This test is very widely used to provide a quick and validated test of strength, balance and coordination. The test has a roof effect, so it is not suitable for capturing very small and subtle self-perceived disturbances in function. The test is very sensitive to change in the target group.
Grip strength
Time frame: 0+6+12 months after end of treatment period
There is a recognized and validated connection between general function and health and grip strength, as well as between grip strength and life span. Grip strength changes as other function changes.
Fatigue Severity Scale (FSC)
Time frame: 0+6+12 months after end of treatment period
A major problem after stroke and in many brain disorders is fatigue. Fatigue leads to reduced foxing and thus loss of function. The test is believed to be able to detect changes that are relevant to everyday life function and social participation.
Canadian Occupational Performance Measure (COPM)
Time frame: 0+6+12 months after end of treatment period
COPM is designed to help people identify and prioritize activity problems, as well as evaluate activity performance and satisfaction with activity execution. In an interview, the person is asked to describe activities they consider important but find it difficult to perform. Among the aforementioned challenges, the person is asked to prioritize a maximum of five activities he / she wants to be able to perform better after the end of treatment. Then, the person is asked to score the current performance and satisfaction with the current performance of priority activities. The score scale is from 1-10 where 10 indicates very good workmanship or high satisfaction. After the interview, partial scores for execution (COPM-U) and satisfaction (COPM-T) are calculated. A change score of 3 points is considered a clinically important change. COPM has shown good measurement properties, among other things for participants with stroke and the elderly.
Action Research Arm Test (ARAT)
Time frame: 0+6+12 months after end of treatment period
ARAT is a tool designed to assess motor function in the arm after stroke. The tasks in the test reflect daily activities and the patient's ability to perform them. The test contains 19 sub-tasks in which different grips (five-finger grips, cylinder grips, tweezers grips), as well as gross motor skills are specifically assessed. In each of the 19 tasks, a score is given from 0-3, where high scores indicate good arm function. The total score (0-57) is the sum of the sub-scores. The test has shown promising measurement properties. For participants in the chronic and subacute phase after stroke, a change of 5.7 points (10%) is considered clinically important. Norwegian guidelines will be used in the study.
Nine Hole Peg Test (NHPT)
Time frame: 0+6+12 months after end of treatment period
NHPT is a simple test of fine motor skills that is recommended, among other things, for participants with stroke. Scoring is based on the time the patient spends in placing and removing nine small pieces in nine holes. Total time (maximum 50 seconds) and total number of pins are indicated. The test has shown satisfactory reliability and validity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Background: PubMed 28616361Heyboer M 3rd, Sharma D, Santiago W, McCulloch N. Hyperbaric Oxygen Therapy: Side Effects Defined and Quantified. Adv Wound Care (New Rochelle). 2017 Jun 1;6(6):210-224. doi: 10.1089/wound.2016.0718.
- Background: PubMed 10685584Plafki C, Peters P, Almeling M, Welslau W, Busch R. Complications and side effects of hyperbaric oxygen therapy. Aviat Space Environ Med. 2000 Feb;71(2):119-24.
- Background: PubMed 23146993Mu J, Ostrowski RP, Soejima Y, Rolland WB, Krafft PR, Tang J, Zhang JH. Delayed hyperbaric oxygen therapy induces cell proliferation through stabilization of cAMP responsive element binding protein in the rat model of MCAo-induced ischemic brain injury. Neurobiol Dis. 2013 Mar;51:133-43. doi: 10.1016/j.nbd.2012.11.003. Epub 2012 Nov 10.
- Results publication: PubMed 28357821Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017 Mar;47(1):24-32. doi: 10.28920/dhm47.1.24-32.
- Results publication: PubMed 16510383Al-Waili NS, Butler GJ, Beale J, Abdullah MS, Hamilton RW, Lee BY, Lucus P, Allen MW, Petrillo RL, Carrey Z, Finkelstein M. Hyperbaric oxygen in the treatment of patients with cerebral stroke, brain trauma, and neurologic disease. Adv Ther. 2005 Nov-Dec;22(6):659-78. doi: 10.1007/BF02849960.
- Results publication: PubMed 24471697Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29.
- Results publication: PubMed 30402285Rosario ER, Kaplan SE, Khonsari S, Vazquez G, Solanki N, Lane M, Brownell H, Rosenberg SS. The Effect of Hyperbaric Oxygen Therapy on Functional Impairments Caused by Ischemic Stroke. Neurol Res Int. 2018 Oct 9;2018:3172679. doi: 10.1155/2018/3172679. eCollection 2018.
- Results publication: PubMed 20954243Wang W, Osenbroch P, Skinnes R, Esbensen Y, Bjoras M, Eide L. Mitochondrial DNA integrity is essential for mitochondrial maturation during differentiation of neural stem cells. Stem Cells. 2010 Dec;28(12):2195-204. doi: 10.1002/stem.542.
- Results publication: PubMed 23335971Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
- Results publication: PubMed 19949909Godman CA, Chheda KP, Hightower LE, Perdrizet G, Shin DG, Giardina C. Hyperbaric oxygen induces a cytoprotective and angiogenic response in human microvascular endothelial cells. Cell Stress Chaperones. 2010 Jul;15(4):431-42. doi: 10.1007/s12192-009-0159-0. Epub 2009 Dec 1.
- Results publication: PubMed 16457083Vila JF, Balcarce PE, Abiusi GR, Dominguez RO, Pisarello JB. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: a prospective single-blind controlled trial. Undersea Hyperb Med. 2005 Sep-Oct;32(5):341-9.
- The effects of combined hyperbaric oxygen therapy on patients with post-stroke depressionLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Tobba T Südmann, PhD principal investigator
Western Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric oxygen in people with Cerebral Stroke, run by Norwegian Underwater Intervention (NUI) at 1 site in Norway.
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 0 inclusion and 20 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: withdrawn, as of the sponsor's last update on 27 Apr 2020. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improved physical and cognitive function in activities of daily living. (time frame: 0+6+12 months after end of treatment period). The study lists 7 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 NCT04149379, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.