IntubationNCT04782817
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
A study testing Recommendation for high flow nasal cannula oxygen therapy order set in people with Intubation and Cardiovascular Surgical Procedure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Cardiovascular Surgical Procedure
- What is being tested?
- Recommendation for high flow nasal cannula oxygen therapy order set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,568 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Undergoing cardiac surgery, defined as a documented surgical service of "cardiac surgery" in the electronic health record, performed in the main operating rooms at Vanderbilt University Medical Center
- Admitted to the cardiovascular intensive care unit postoperatively with an endotracheal tube in place and mechanically ventilated
- Surgery duration (documented time between "Anesthesia start" and "Anesthesia stop" in the EHR) of at least 180 minutes
- Received an order to be extubated by a treating provider o Patients who meet all other criteria but do not receive an order to extubate will be randomized but not enrolled
Who cannot join
- Patient does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation).
Read the detailed description
HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit along with other therapies, including: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.
This prospective, randomized, pragmatic clinical trial will compare HFNC to provider choice of usual care in these high-risk patients.
Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.
- Conditions
- Intubation, Cardiovascular Surgical Procedure
- Being tested
- Recommendation for high flow nasal cannula oxygen therapy order set, Provider choice usual care order set
- Keywords
- High-flow nasal cannula oxygen therapy, Reintubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendation for high flow nasal cannula oxygen therapy order setOther
Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
Provider choice usual care order setOther
Participants will receive order set with provider choice of usual care therapy.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Canula Oxygen Therapy | Experimental | Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates. Receives: Other: Recommendation for high flow nasal cannula oxygen therapy order set |
| Provider Choice Usual Care | Active comparator | Participants be assigned standard provider choice of usual care therapy physician order set. Receives: Other: Provider choice usual care order set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reintubation Within 48 Hours of Extubation
Reintubation within 48 hours of initial extubation after cardiac surgery
Measured: 48 hours
Secondary outcomes (7)
Number of Participants With Reintubation Within 72 Hours of Extubation
Reintubation within 72 hours of initial extubation after cardiac surgery
Measured: 72 hours
Number of Participants With Reintubation After Cardiac Surgery
Reintubation any time after initial extubation following cardiac surgery
Measured: From initial extubation following cardiac surgery to hospital discharge, an average of 8 days.
Number of Participants With All Cause Mortality
Mortality occurring within 30 days following cardiac surgery.
Measured: 30 days post surgery
Hospital Length of Stay
Length of stay within the hospital
Measured: From end of surgery on Day 1 to end of hospital stay, assessed up to approximately 3 weeks
Intensive Care Unit Length of Stay
Intensive Care Unit length of stay after cardiac surgery
Measured: 3 days
Ventilator-free Days
Number of days free from mechanical ventilation following cardiac surgery
Measured: 30 days
Number of Participants With In-hospital Mortality
Mortality occurring during the index hospitalization following cardiac surgery
Measured: From initial extubation following cardiac surgery to hospital discharge, an average of 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Nov 2021
- Primary completion19 Nov 2025
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert Freundlich, Vanderbilt University Medical Center
- Investigators
- Robert E Freundlich, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782817
- Sponsor's protocol ID
- 181117
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2021
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khandelwal N, Dale CR, Benkeser DC, Joffe AM, Yanez ND 3rd, Treggiari MM. Variation in tracheal reintubations among patients undergoing cardiac surgery across Washington state hospitals. J Cardiothorac Vasc Anesth. 2015;29(3):551-9. doi: 10.1053/j.jvca.2014.11.009. Epub 2014 Nov 11.
PubMed 25802193Freundlich RE, Maile MD, Hajjar MM, Habib JR, Jewell ES, Schwann T, Habib RH, Engoren M. Years of Life Lost After Complications of Coronary Artery Bypass Operations. Ann Thorac Surg. 2017 Jun;103(6):1893-1899. doi: 10.1016/j.athoracsur.2016.09.048. Epub 2016 Dec 6.
PubMed 27938887Dorsa AG, Rossi AI, Thierer J, Lupianez B, Vrancic JM, Vaccarino GN, Piccinini F, Raich H, Bonazzi SV, Benzadon M, Navia DO. Immediate extubation after off-pump coronary artery bypass graft surgery in 1,196 consecutive patients: feasibility, safety and predictors of when not to attempt it. J Cardiothorac Vasc Anesth. 2011 Jun;25(3):431-6. doi: 10.1053/j.jvca.2010.08.013. Epub 2010 Oct 29.
PubMed 21036063Chan JL, Miller JG, Murphy M, Greenberg A, Iraola M, Horvath KA. A Multidisciplinary Protocol-Driven Approach to Improve Extubation Times After Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1684-1690. doi: 10.1016/j.athoracsur.2018.02.008. Epub 2018 Mar 9.
PubMed 29530778Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z.
PubMed 27121707Markovitz GH, Colthurst J, Storer TW, Cooper CB. Effective inspired oxygen concentration measured via transtracheal and oral gas analysis. Respir Care. 2010 Apr;55(4):453-9.
PubMed 20406513Bazuaye EA, Stone TN, Corris PA, Gibson GJ. Variability of inspired oxygen concentration with nasal cannulas. Thorax. 1992 Aug;47(8):609-11. doi: 10.1136/thx.47.8.609.
PubMed 1412117Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
PubMed 25980660Masip J, Peacock WF, Price S, Cullen L, Martin-Sanchez FJ, Seferovic P, Maisel AS, Miro O, Filippatos G, Vrints C, Christ M, Cowie M, Platz E, McMurray J, DiSomma S, Zeymer U, Bueno H, Gale CP, Lettino M, Tavares M, Ruschitzka F, Mebazaa A, Harjola VP, Mueller C; Acute Heart Failure Study Group of the Acute Cardiovascular Care Association and the Committee on Acute Heart Failure of the Heart Failure Association of the European Society of Cardiology. Indications and practical approach to non-invasive ventilation in acute heart failure. Eur Heart J. 2018 Jan 1;39(1):17-25. doi: 10.1093/eurheartj/ehx580.
PubMed 29186485Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
PubMed 21908497Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
PubMed 19846404Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. J Crit Care. 2017 Apr;38:123-128. doi: 10.1016/j.jcrc.2016.10.027. Epub 2016 Nov 9.
PubMed 27886577Freundlich RE, Wanderer JP, French B, Moore RP, Hernandez A, Shah AS, Byrne DW, Pandharipande PP. Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN). BMJ Open. 2022 Nov 25;12(11):e066007. doi: 10.1136/bmjopen-2022-066007.
PubMed 36428016
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT04782817
- Acronym / sponsor ID
- 181117
- Conditions
- Intubation, Cardiovascular Surgical Procedure
- Keywords
- High-flow nasal cannula oxygen therapy, Reintubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,568 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation).
Detailed description
HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit along with other therapies, including: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.
This prospective, randomized, pragmatic clinical trial will compare HFNC to provider choice of usual care in these high-risk patients.
Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Canula Oxygen Therapy | Experimental | Other: Recommendation for high flow nasal cannula oxygen therapy order setParticipants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates. |
| Provider Choice Usual Care | Active comparator | Other: Provider choice usual care order setParticipants be assigned standard provider choice of usual care therapy physician order set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Undergoing cardiac surgery, defined as a documented surgical service of "cardiac surgery" in the electronic health record, performed in the main operating rooms at Vanderbilt University Medical Center
- Admitted to the cardiovascular intensive care unit postoperatively with an endotracheal tube in place and mechanically ventilated
- Surgery duration (documented time between "Anesthesia start" and "Anesthesia stop" in the EHR) of at least 180 minutes
- Received an order to be extubated by a treating provider o Patients who meet all other criteria but do not receive an order to extubate will be randomized but not enrolled
Key exclusion criteria (1 listed)
- Patient does not meet inclusion criteria
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 |
|---|---|---|
| Recommendation for high flow nasal cannula oxygen therapy order setParticipants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates. | Other | High Flow Nasal Canula Oxygen Therapy |
| Provider choice usual care order setParticipants will receive order set with provider choice of usual care therapy. | Other | Provider Choice Usual Care |
Primary outcome
Number of Participants With Reintubation Within 48 Hours of Extubation
Time frame: 48 hours
Reintubation within 48 hours of initial extubation after cardiac surgery
7 secondary outcomes
Number of Participants With Reintubation Within 72 Hours of Extubation
Time frame: 72 hours
Number of Participants With Reintubation After Cardiac Surgery
Time frame: From initial extubation following cardiac surgery to hospital discharge, an average of 8 days.
Number of Participants With All Cause Mortality
Time frame: 30 days post surgery
Hospital Length of Stay
Time frame: From end of surgery on Day 1 to end of hospital stay, assessed up to approximately 3 weeks
Intensive Care Unit Length of Stay
Time frame: 3 days
Ventilator-free Days
Time frame: 30 days
Number of Participants With In-hospital Mortality
Time frame: From initial extubation following cardiac surgery to hospital discharge, an average of 8 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25802193Khandelwal N, Dale CR, Benkeser DC, Joffe AM, Yanez ND 3rd, Treggiari MM. Variation in tracheal reintubations among patients undergoing cardiac surgery across Washington state hospitals. J Cardiothorac Vasc Anesth. 2015;29(3):551-9. doi: 10.1053/j.jvca.2014.11.009. Epub 2014 Nov 11.
- Background: PubMed 27938887Freundlich RE, Maile MD, Hajjar MM, Habib JR, Jewell ES, Schwann T, Habib RH, Engoren M. Years of Life Lost After Complications of Coronary Artery Bypass Operations. Ann Thorac Surg. 2017 Jun;103(6):1893-1899. doi: 10.1016/j.athoracsur.2016.09.048. Epub 2016 Dec 6.
- Background: PubMed 21036063Dorsa AG, Rossi AI, Thierer J, Lupianez B, Vrancic JM, Vaccarino GN, Piccinini F, Raich H, Bonazzi SV, Benzadon M, Navia DO. Immediate extubation after off-pump coronary artery bypass graft surgery in 1,196 consecutive patients: feasibility, safety and predictors of when not to attempt it. J Cardiothorac Vasc Anesth. 2011 Jun;25(3):431-6. doi: 10.1053/j.jvca.2010.08.013. Epub 2010 Oct 29.
- Background: PubMed 29530778Chan JL, Miller JG, Murphy M, Greenberg A, Iraola M, Horvath KA. A Multidisciplinary Protocol-Driven Approach to Improve Extubation Times After Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1684-1690. doi: 10.1016/j.athoracsur.2018.02.008. Epub 2018 Mar 9.
- Background: PubMed 27121707Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z.
- Background: PubMed 20406513Markovitz GH, Colthurst J, Storer TW, Cooper CB. Effective inspired oxygen concentration measured via transtracheal and oral gas analysis. Respir Care. 2010 Apr;55(4):453-9.
- Background: PubMed 1412117Bazuaye EA, Stone TN, Corris PA, Gibson GJ. Variability of inspired oxygen concentration with nasal cannulas. Thorax. 1992 Aug;47(8):609-11. doi: 10.1136/thx.47.8.609.
- Background: PubMed 25980660Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
- Background: PubMed 29186485Masip J, Peacock WF, Price S, Cullen L, Martin-Sanchez FJ, Seferovic P, Maisel AS, Miro O, Filippatos G, Vrints C, Christ M, Cowie M, Platz E, McMurray J, DiSomma S, Zeymer U, Bueno H, Gale CP, Lettino M, Tavares M, Ruschitzka F, Mebazaa A, Harjola VP, Mueller C; Acute Heart Failure Study Group of the Acute Cardiovascular Care Association and the Committee on Acute Heart Failure of the Heart Failure Association of the European Society of Cardiology. Indications and practical approach to non-invasive ventilation in acute heart failure. Eur Heart J. 2018 Jan 1;39(1):17-25. doi: 10.1093/eurheartj/ehx580.
- Background: PubMed 21908497Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
- Background: PubMed 19846404Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
- Background: PubMed 27886577Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. J Crit Care. 2017 Apr;38:123-128. doi: 10.1016/j.jcrc.2016.10.027. Epub 2016 Nov 9.
- 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.
Robert E Freundlich, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendation for high flow nasal cannula oxygen therapy order set in people with Intubation and Cardiovascular Surgical Procedure, run by Vanderbilt University Medical Center 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 5 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: finished, as of the sponsor's last update on 27 Oct 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 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?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Reintubation Within 48 Hours of Extubation (time frame: 48 hours). 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 NCT04782817, 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 27 Oct 2026.