Delayed Sequence IntubationDSI vs RSINCT07380763
Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols
A study testing Delayed Sequence Intubation and Rapid Sequence Intubation in people with Delayed Sequence Intubation and Rapid Sequence Induction and Intubation, run by Kanuni Sultan Suleyman Training and Research Hospital at 4 sites in Turkey (Türkiye).
Trial summary
This study compares two different methods of helping patients breathe by placing a tube in their airway (intubation) in an emergency setting. These methods are called Rapid Sequence Intubation (RSI) and Delayed Sequence Intubation (DSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Sequence Intubation, Rapid Sequence Induction and Intubation, Intubation
- What is being tested?
- Delayed Sequence Intubation and Rapid Sequence Intubation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 29 Oct 2025to 29 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Presence of spontaneous breathing.
- No prediction of a difficult airway prior to intubation.
- Requirement for advanced airway management.
- Not in cardiac arrest.
- Decided to intubate due to non-traumatic etiologies.
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- Planned intubation using ketamine for sedation and rocuronium for paralysis.
- Decision to intubate due to one of the following clinical conditions:
- Acute Respiratory Failure: Patients with hypoxic or hypercapnic respiratory failure where adequate oxygenation cannot be achieved despite non-invasive ventilation.
- Inability to Protect the Airway: Altered level of consciousness or increased risk of pulmonary aspiration due to conditions such as upper gastrointestinal bleeding, ileus, volvulus, gastric outlet obstruction, hypersalivation, or hyperemesis.
- Shock States: Patients in any state of shock (hypovolemic, distributive, cardiogenic, obstructive) exhibiting severe altered mental status or declining respiratory status.
- Neuroprotection: Need to terminate ongoing seizures resistant to medical therapy (status epilepticus), or situations requiring strict control of arterial carbon dioxide (PaCO₂) levels to manage increased intracranial pressure (ICP) in non-traumatic conditions (such as intracranial hemorrhage or severe encephalopathy).
- Obtaining informed consent from the patient or their legally authorized representative.
Who cannot join
- Aged under 18 years.
- Pregnancy.
- Refusal to provide informed consent.
- Cardiac arrest prior to intubation.
- Anticipated difficult airway.
- Intubation required due to traumatic etiologies.
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- Missing or incomplete patient data.
- Patients assigned to the DSI protocol but for whom the decision to intubate was rescinded due to clinical improvement during the preoxygenation phase.
- Use of a sedative agent other than ketamine for the RSI protocol.
- Intubations performed by practitioners who have not received study-specific training on DSI and RSI protocols.
- Duplicate enrollment due to recurrent presentations during the study period.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, 34170
Nihat Mujdat Hokenek, Assoc. Prof. Dr., +90-555-320-14-19, nihathokenek@gmail.com
Nihat Mujdat Hokenek, Associate Professor
- Recruiting
İstanbul Haseki Training and Research Hospital
Istanbul
Özgür Söğüt, Professor Doctor, +90-533-669-26-87, ozgur.sogut@sbu.edu.tr
Özgür Söğüt, Professor
- Recruiting
Kanuni Sultan Süleyman Research and Training Hospital
Istanbul
Utku Murat Kalafat, Associate Professor, +90-507-262-74-04, utkumuratk@yahoo.com
Muhammed Güner, Resident Doctor, +90-543-765-46-93, muhammedgner@gmail.com
- Recruiting
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
Ertuğrul Altınbilek, Associate Professor, +90-505-904-68-33, ertugrul.altinbilek@sbu.edu.tr
Ertuğrul Altınbilek, Associate Professor
About this study
Official title: Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Sequential Intubation (DSI) Versus Rapid Sequence Intubation (RSI) Protocols
This study compares two different methods of helping patients breathe by placing a tube in their airway (intubation) in an emergency setting. These methods are called Rapid Sequence Intubation (RSI) and Delayed Sequence Intubation (DSI).
The study focuses on adult patients who are still breathing on their own but need a breathing tube for medical reasons not related to an injury (non-trauma).
Read more
The main goal of the research is to compare:
- Oxygen levels before and after the procedure.
- The patient's vital signs (such as heart rate and blood pressure).
- The number of attempts needed to successfully place the tube and the time the procedure takes.
- Blood gas results and any complications that occur during or shortly after the procedure.
- Early survival (mortality) rates.
While there are previous studies on trauma patients or small observational reports, there is currently no large-scale, multicenter randomized controlled trial that includes all non-trauma adult patients.
What makes this study unique? Confirmation of Tube Placement: Researchers will use a specific measurement called end-tidal CO2 (etCO2) to confirm the tube is in the right place, a method not used in similar previous studies.
Assessing Difficulty: This study will use the Cormack-Lehane classification system to measure how difficult the intubation was for each patient.
Standardization: For the first time, breathing machine (ventilator) settings will be standardized for all patients in this type of study.
Real-World Practice: By involving all emergency department physicians as practitioners, the study aims to show how these methods work across a wide range of medical teams.
- Conditions
- Delayed Sequence Intubation, Rapid Sequence Induction and Intubation, Intubation, Intubation Complications, Intubation, Endotracheal
- Being tested
- Delayed Sequence Intubation, Rapid Sequence Intubation
- Keywords
- delayed sequence intubation, rapid sequence intubation, RSI, DSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Sequence IntubationProcedure or surgery
Patients assigned to the Delayed Sequence Intubation (DSI) protocol will receive an initial dose of 1 mg/kg ketamine. Titrated additional doses of 0.5 mg/kg will be administered until 'adequate sedation/dissociation' is achieved, ensuring the preservation of airway reflexes and spontaneous respiration. Subsequently, 'preoxygenation' will be performed for 3 minutes with 'appropriate positioning,' using a non-rebreather mask or bag-valve-mask combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min). Following the induction of paralysis with an intravenous push of rocuronium (1 mg/kg), endotracheal intubation will be performed using direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician.
Rapid Sequence IntubationProcedure or surgery
Patients assigned to the Rapid Sequence Intubation (RSI) protocol will receive 'preoxygenation' for 3 minutes using a non-rebreather mask (NRM) or bag-valve-mask (BVM) combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min), following the necessary preparation period. Subsequently, appropriate sedation and paralysis will be achieved through the sequential administration of intravenous (IV) ketamine (1 mg/kg push) and rocuronium (1 mg/kg IV push). Following induction, endotracheal intubation will be performed via direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician
| Study group | Role | What they receive |
|---|---|---|
| Delayed Sequence Intubation | Experimental | Not described Receives: Procedure: Delayed Sequence Intubation |
| Rapid Sequence Intubation | Active comparator | Not described Receives: Procedure: Rapid Sequence Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Procedure-Related Adverse Events
Hypoxia(Spo2<90), hypotension (systolic blood pressure <90mmHg or blood pressure drop >20mmg after intiation of intubation protocol), orogastric intubation, cardiac arrest, orolaryngeal trauma, aspiration of orogastric fluid is accepted as procedure-related adverse events
Measured: During and 1 hours after intubation
Mean Peripheral Oxygen Saturation (SpO2)
Spo2 levels at admission, when intubation decision made, Spo2 level upon commencement of the intubation protocol(0-min); Spo2 level at 1st minute, 2nd minute, 3rd minute of intubation protocol, during blade passes incisor teeth, 1 minutes after intubation, 5 minutes after intubation wil be recorded
Measured: Hospital admission, Intubation decision, Protocol start (0 min), Minutes 1, 2, 3 of protocol, During blade insertion, 1 minute post-intubation, and 5 minutes post-intubation
Mean Arterial Blood pH Levels
Evaluation of acid-base status.
Measured: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Partial Pressure of Carbon Dioxide (PaCO2)
Measure of carbon dioxide in arterial blood.
Measured: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Arterial Bicarbonate (HCO3) Concentration
Measure of bicarbonate in arterial blood.
Measured: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Base Excess (BE) Levels
Measure of base excess in arterial blood.
Measured: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Arterial Lactate Concentration
Measure of lactate in arterial blood.
Measured: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
First Hour Mortality
Death from any cause within 60 minutes following the intubation attempt.
Measured: 1 hour later intubation
28th day mortality
All-cause mortality recorded during the first 28 days after enrollment.
Measured: 28 days after intubation
Secondary outcomes (2)
Number of intubation attempts
From the initiation of intubation until successful intubation is achieved.
Measured: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
Intubation Duration
Time from the laryngoscope blade passing the incisors until successful ETT placement.
Measured: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start29 Oct 2025
- Primary completion29 May 2026 (estimated)
- Study completion29 Jun 2026 (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 Delayed Sequence IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Murat Kalafat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380763
- Sponsor's protocol ID
- 4975
- Other IDs
- 2024-KAEK-18
- Acronym
- DSI vs RSI
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication and upon reasonable request
Publications
Mosier JM, Joshi R, Hypes C, Pacheco G, Valenzuela T, Sakles JC. The Physiologically Difficult Airway. West J Emerg Med. 2015 Dec;16(7):1109-17. doi: 10.5811/westjem.2015.8.27467. Epub 2015 Dec 8.
PubMed 26759664Weingart SD, Trueger NS, Wong N, Scofi J, Singh N, Rudolph SS. Delayed sequence intubation: a prospective observational study. Ann Emerg Med. 2015 Apr;65(4):349-55. doi: 10.1016/j.annemergmed.2014.09.025. Epub 2014 Oct 23.
PubMed 25447559Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PubMed 22050948Stanke L, Nakajima S, Zimmerman LH, Collopy K, Fales C, Powers W 4th. Hemodynamic Effects of Ketamine Versus Etomidate for Prehospital Rapid Sequence Intubation. Air Med J. 2021 Sep-Oct;40(5):312-316. doi: 10.1016/j.amj.2021.05.009. Epub 2021 Jul 2.
PubMed 34535237Sehdev RS, Symmons DA, Kindl K. Ketamine for rapid sequence induction in patients with head injury in the emergency department. Emerg Med Australas. 2006 Feb;18(1):37-44. doi: 10.1111/j.1742-6723.2006.00802.x.
PubMed 16454773
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Sequential Intubation (DSI) Versus Rapid Sequence Intubation (RSI) Protocols
- ClinicalTrials.gov ID
- NCT07380763
- Acronym / sponsor ID
- DSI vs RSI / 4975
- Conditions
- Delayed Sequence Intubation, Rapid Sequence Induction and Intubation, Intubation, Intubation Complications, Intubation, Endotracheal
- Keywords
- delayed sequence intubation, rapid sequence intubation, RSI, DSI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 2 Feb 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.
This study compares two different methods of helping patients breathe by placing a tube in their airway (intubation) in an emergency setting. These methods are called Rapid Sequence Intubation (RSI) and Delayed Sequence Intubation (DSI).
The study focuses on adult patients who are still breathing on their own but need a breathing tube for medical reasons not related to an injury (non-trauma).
The main goal of the research is to compare:
- Oxygen levels before and after the procedure.
- The patient's vital signs (such as heart rate and blood pressure).
- The number of attempts needed to successfully place the tube and the time the procedure takes.
- Blood gas results and any complications that occur during or shortly after the procedure.
- Early survival (mortality) rates.
While there are previous studies on trauma patients or small observational reports, there is currently no large-scale, multicenter randomized controlled trial that includes all non-trauma adult patients.
What makes this study unique? Confirmation of Tube Placement: Researchers will use a specific measurement called end-tidal CO2 (etCO2) to confirm the tube is in the right place, a method not used in similar previous studies.
Assessing Difficulty: This study will use the Cormack-Lehane classification system to measure how difficult the intubation was for each patient.
Standardization: For the first time, breathing machine (ventilator) settings will be standardized for all patients in this type of study.
Real-World Practice: By involving all emergency department physicians as practitioners, the study aims to show how these methods work across a wide range of medical teams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Sequence Intubation | Experimental | Procedure: Delayed Sequence Intubation |
| Rapid Sequence Intubation | Active comparator | Procedure: Rapid Sequence Intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 years or older
- Presence of spontaneous breathing.
- No prediction of a difficult airway prior to intubation.
- Requirement for advanced airway management.
- Not in cardiac arrest.
Key exclusion criteria (11 listed)
- Aged under 18 years.
- Pregnancy.
- Refusal to provide informed consent.
- Cardiac arrest prior to intubation.
- Anticipated difficult airway.
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 |
|---|---|---|
| Delayed Sequence IntubationPatients assigned to the Delayed Sequence Intubation (DSI) protocol will receive an initial dose of 1 mg/kg ketamine. Titrated additional doses of 0.5 mg/kg will be administered until 'adequate sedation/dissociation' is achieved, ensuring the preservation of airway reflexes and spontaneous respiration. Subsequently, 'preoxygenation' will be performed for 3 minutes with 'appropriate positioning,' using a non-rebreather mask or bag-valve-mask combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min). Following the induction of paralysis with an intravenous push of rocuronium (1 mg/kg), endotracheal intubation will be performed using direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician. | Procedure or surgery | Delayed Sequence Intubation |
| Rapid Sequence IntubationPatients assigned to the Rapid Sequence Intubation (RSI) protocol will receive 'preoxygenation' for 3 minutes using a non-rebreather mask (NRM) or bag-valve-mask (BVM) combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min), following the necessary preparation period. Subsequently, appropriate sedation and paralysis will be achieved through the sequential administration of intravenous (IV) ketamine (1 mg/kg push) and rocuronium (1 mg/kg IV push). Following induction, endotracheal intubation will be performed via direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician | Procedure or surgery | Rapid Sequence Intubation |
Primary outcome
Number of Participants with Procedure-Related Adverse Events
Time frame: During and 1 hours after intubation
Hypoxia(Spo2<90), hypotension (systolic blood pressure <90mmHg or blood pressure drop >20mmg after intiation of intubation protocol), orogastric intubation, cardiac arrest, orolaryngeal trauma, aspiration of orogastric fluid is accepted as procedure-related adverse events
Mean Peripheral Oxygen Saturation (SpO2)
Time frame: Hospital admission, Intubation decision, Protocol start (0 min), Minutes 1, 2, 3 of protocol, During blade insertion, 1 minute post-intubation, and 5 minutes post-intubation
Spo2 levels at admission, when intubation decision made, Spo2 level upon commencement of the intubation protocol(0-min); Spo2 level at 1st minute, 2nd minute, 3rd minute of intubation protocol, during blade passes incisor teeth, 1 minutes after intubation, 5 minutes after intubation wil be recorded
Mean Arterial Blood pH Levels
Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Evaluation of acid-base status.
Mean Partial Pressure of Carbon Dioxide (PaCO2)
Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of carbon dioxide in arterial blood.
Mean Arterial Bicarbonate (HCO3) Concentration
Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of bicarbonate in arterial blood.
Mean Base Excess (BE) Levels
Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of base excess in arterial blood.
Mean Arterial Lactate Concentration
Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of lactate in arterial blood.
First Hour Mortality
Time frame: 1 hour later intubation
Death from any cause within 60 minutes following the intubation attempt.
28th day mortality
Time frame: 28 days after intubation
All-cause mortality recorded during the first 28 days after enrollment.
2 secondary outcomes
Number of intubation attempts
Time frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
Intubation Duration
Time frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
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 2 Feb 2026.
- Background: PubMed 26759664Mosier JM, Joshi R, Hypes C, Pacheco G, Valenzuela T, Sakles JC. The Physiologically Difficult Airway. West J Emerg Med. 2015 Dec;16(7):1109-17. doi: 10.5811/westjem.2015.8.27467. Epub 2015 Dec 8.
- Background: PubMed 25447559Weingart SD, Trueger NS, Wong N, Scofi J, Singh N, Rudolph SS. Delayed sequence intubation: a prospective observational study. Ann Emerg Med. 2015 Apr;65(4):349-55. doi: 10.1016/j.annemergmed.2014.09.025. Epub 2014 Oct 23.
- Background: PubMed 22050948Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
- Background: PubMed 34535237Stanke L, Nakajima S, Zimmerman LH, Collopy K, Fales C, Powers W 4th. Hemodynamic Effects of Ketamine Versus Etomidate for Prehospital Rapid Sequence Intubation. Air Med J. 2021 Sep-Oct;40(5):312-316. doi: 10.1016/j.amj.2021.05.009. Epub 2021 Jul 2.
- Background: PubMed 16454773Sehdev RS, Symmons DA, Kindl K. Ketamine for rapid sequence induction in patients with head injury in the emergency department. Emerg Med Australas. 2006 Feb;18(1):37-44. doi: 10.1111/j.1742-6723.2006.00802.x.
- Individual participant dataSharing planned: Yes. After publication and upon reasonable request
Related trials for Delayed Sequence Intubation
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Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
Intubation in Intensive Care Units
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Sequence Intubation and Rapid Sequence Intubation in people with Delayed Sequence Intubation and Rapid Sequence Induction and Intubation, run by Kanuni Sultan Suleyman Training and Research Hospital at 4 sites in Turkey (Türkiye).
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 13 inclusion and 11 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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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 Utku Murat Kalafat, Associate Professor (+90-507-262-74-04, utkumuratk@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Procedure-Related Adverse Events (time frame: During and 1 hours after intubation). The study lists 9 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 NCT07380763, 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 2 Feb 2026.