Upper Gastrointestinal BleedingNCT06350864
HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU
A study testing High-flow nasal cannula (HFNC), Conventional nasal oxygen therapy (COT) and Upper gastrointestinal endoscopy (UGE) including gastroscopy in people with Upper Gastrointestinal Bleeding, run by Ain Shams University at 1 site in Egypt.
Trial summary
Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- High-flow nasal cannula (HFNC), Conventional nasal oxygen therapy (COT) and Upper gastrointestinal endoscopy (UGE) including gastroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2024to 20 Sep 2024
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females with age 20-60 years
- American Society of Anesthesiologists (ASA) class I, II or III
- Patients will undergo UGI endoscopic procedure with anticipated procedure time of over 15 minutes because of complexity of the procedure or recurrence, as assessed by the consultant gastroenterologist responsible for the case
Who cannot join
- Patient refusal or propofol allergy history.
- Suspected difficult airway or Mallampati score more than 3
- Body mass index (BMI) more than 35 kg/m2 (weight will be measured in kilograms and height in meters,then BMI will be measured by equation where: BMI=weight(Kg) / height square (m2))
- Pregnant patients
- Respiratory compromise as patients dependent on supplemental oxygen including respiratory failure or with active chest condition e.g. bronchial asthma or pneumonia
- Cardiovascular compromise including heart failure and shocked patients
- Severe uncontrolled hematemesis with shocked or risk of aspiration.
- Patients deemed as high risk of SRAEs by the anesthesiologist, anticipated requirement or plan for general anesthesia involving airway instrumentation including a laryngeal mask or tracheal intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Cannula (HFNC) Oxygen Therapy Versus Conventional Nasal Oxygen Therapy (COT) in Prolonged Upper Gastrointestinal (UGI) Endoscopy Inside the Intensive Care Unit (ICU): a Prospective, Randomized, Controlled Clinical Study
Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) .
Read the detailed description
Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt. Consented and enrolled seventy patients will be randomly assigned to one of the following two groups:
- Conventional nasal oxygen therapy (COT) group (35 patients): Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case.
- High-flow nasal cannula (HFNC) group (35 patients): Who will receive 30 L/min oxygen flow through Vapotherm Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4,temperature at 37◦C with 100% humidity
- Upper Gastrointestinal (UGI) Endoscopic and anesthetic care as following:
- Pre-procedural full medical and anesthetic history, clinical examination and revision of routine investigations and radiological images will be done.
- Standard monitoring via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SpO2 as a percentage) and non invasive blood pressure (NIBP) (mmHg).
- The intravenous access (IV) will be assessed and flow will be assured
- After positioning the patient in the left lateral position, he will receive either HFNC or COT.
- All UGI endoscopic procedures will be performed by an accredited gastroenterologist. Anesthetic care will be provided by an accredited specialist anesthesiologist. After confirming the readiness of the endoscopist, all patients will undergo deep sedation under monitored anesthetic care with the use of initial slow intravenous (IV) propofol 0.5-1mg/kg over 3-5 minutes which will be titrated to the desired clinical response.Intermittent boluses of 10-20 mg will be used as maintenance and will also be titrated to the desired sedation level. Both the endoscopist and anesthesiologist will be instructed to provide the usual care except for the participant's assigned oxygen delivery device and rate.
- Interventions to change the oxygen delivery rate, Fio2 or even intubation with invasive mechanical ventilation in response to hypoxia will be at the discretion of the anesthesiologist in charge.
- UGI diagnostic and therapeutic endoscopy will be performed by PentaxR Medical 90k series gastroscopy. Therapeutic gastroscopy will include variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.
- Patients will continue their monitored care in the medical ICU till the control of the causes of their ICU admission or their end.
- Demographics and medical conditions will be collected from the medical records and anesthesiologist assessments. Oxygenation, anesthetic and procedure-related (intraprocedural and shortly post- procedural) data will be collected also. The collected data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between both groups to identify any significant differences between them
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- High-flow nasal cannula (HFNC), Conventional nasal oxygen therapy (COT), Upper gastrointestinal endoscopy (UGE) including gastroscopy, Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)
- Keywords
- High-flow Nasal Cannula (HFNC) Oxygen Therapy, Conventional Nasal Oxygen Therapy (COT), Upper Gastrointestinal (UGI) Endoscopy, Intensive Care Unit (ICU), Hypoxia
- Medical subject headings
- Gastrointestinal Hemorrhage, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula (HFNC)Device
Also called Vapotherm Precision Flow HI-VNI Technology device
high flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39◦ C, humidity minimum of 12mg/liter)
Conventional nasal oxygen therapy (COT)Device
Also called Ultramed
Adult size, single use nasal cannula
Upper gastrointestinal endoscopy (UGE) including gastroscopyDevice
Also called Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).
Upper gastrointestinal endoscopy (UGE) will be either diagnostic and/or therapeutic including variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.
Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)Device
Also called Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).
Upper gastrointestinal endoscopy (UGE) will be diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Conventional nasal oxygen therapy (COT) group (35 patients) | Active comparator | Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case. Receives: Device: Conventional nasal oxygen therapy (COT); Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy; Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) |
| High-flow nasal cannula (HFNC) group (35 patients) | Active comparator | Who will receive 30 L/min oxygen flow through VapothermR Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4, temperature at 37◦C with 100% humidity. Receives: Device: High-flow nasal cannula (HFNC); Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy; Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure.
moderate hypoxemia, defined as SpO2 < 90%
Measured: During the procedure.
Secondary outcomes (6)
The median lowest SpO2
Measured by pulse oximetry during the procedure
Measured: During the procedure
Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes
Hypoxemia may be: mild (SpO2 90%-94%), moderate (SpO2 76%-89%), severe (SpO2 ≤ 75%)
Measured: During the procedure
Clinically significant hypoxia
The need to maneuver the upper airway or to change the flow, Fio2 and/or method of oxygen delivery in response to an episode of hypoxia
Measured: During the procedure
Sedation related adverse effects (SRAEs)
They include hypotension, bradycardia, tachycardia, dysrhythmia, seizure, cardiac arrest, nausea or vomiting, recovery agitation, and delayed recovery
Measured: During the procedure and immediately after the procedure for 6 hours
Procedure-related adverse events (PRAEs)
They include :1. Intra-procedural adverse events: The need to pause or stop the procedure because of an episode of hypoxia, gastrointestinal bleeding requiring intervention or perforation.
- Post-procedure adverse events as abdominal pain, bloating or bleeding, throat dryness, headache,gastrointestinal bleeding requiring intervention or perforation.
Measured: During the procedure and immediately after the procedure for 24 hours
Propofol total used doses in milligrams (mgs)
Propofol total used doses during sedation
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Apr 2024
- Primary completion1 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, comparative, controlled clinical trial study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mohamed, MD, Principal investigator, Ain Shames University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350864
- Sponsor's protocol ID
- FMASU R11/2024
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The statistics methods and results data will be shared after completing the study
Publications
Mohamed AM, Selima WZ. HFNC Oxygen Therapy vs COT in Prolonged Upper Gastrointestinal Endoscopy Inside the ICU: A Prospective, Randomized, Controlled Clinical Study. Indian J Crit Care Med. 2025 Mar;29(3):223-229. doi: 10.5005/jp-journals-10071-24919. Epub 2025 Feb 28.
PubMed 40110237
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula (HFNC) Oxygen Therapy Versus Conventional Nasal Oxygen Therapy (COT) in Prolonged Upper Gastrointestinal (UGI) Endoscopy Inside the Intensive Care Unit (ICU): a Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06350864
- Acronym / sponsor ID
- FMASU R11/2024
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- High-flow Nasal Cannula (HFNC) Oxygen Therapy, Conventional Nasal Oxygen Therapy (COT), Upper Gastrointestinal (UGI) Endoscopy, Intensive Care Unit (ICU), Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 5 Apr 2024 (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.
Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) .
Detailed description
Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt. Consented and enrolled seventy patients will be randomly assigned to one of the following two groups:
- Conventional nasal oxygen therapy (COT) group (35 patients): Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case.
- High-flow nasal cannula (HFNC) group (35 patients): Who will receive 30 L/min oxygen flow through Vapotherm Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4,temperature at 37◦C with 100% humidity
- Upper Gastrointestinal (UGI) Endoscopic and anesthetic care as following:
- Pre-procedural full medical and anesthetic history, clinical examination and revision of routine investigations and radiological images will be done.
- Standard monitoring via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SpO2 as a percentage) and non invasive blood pressure (NIBP) (mmHg).
- The intravenous access (IV) will be assessed and flow will be assured
- After positioning the patient in the left lateral position, he will receive either HFNC or COT.
- All UGI endoscopic procedures will be performed by an accredited gastroenterologist. Anesthetic care will be provided by an accredited specialist anesthesiologist. After confirming the readiness of the endoscopist, all patients will undergo deep sedation under monitored anesthetic care with the use of initial slow intravenous (IV) propofol 0.5-1mg/kg over 3-5 minutes which will be titrated to the desired clinical response.Intermittent boluses of 10-20 mg will be used as maintenance and will also be titrated to the desired sedation level. Both the endoscopist and anesthesiologist will be instructed to provide the usual care except for the participant's assigned oxygen delivery device and rate.
- Interventions to change the oxygen delivery rate, Fio2 or even intubation with invasive mechanical ventilation in response to hypoxia will be at the discretion of the anesthesiologist in charge.
- UGI diagnostic and therapeutic endoscopy will be performed by PentaxR Medical 90k series gastroscopy. Therapeutic gastroscopy will include variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.
- Patients will continue their monitored care in the medical ICU till the control of the causes of their ICU admission or their end.
- Demographics and medical conditions will be collected from the medical records and anesthesiologist assessments. Oxygenation, anesthetic and procedure-related (intraprocedural and shortly post- procedural) data will be collected also. The collected data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between both groups to identify any significant differences between them
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, comparative, controlled clinical trial study
| Arm | Type | Receives |
|---|---|---|
| Conventional nasal oxygen therapy (COT) group (35 patients) | Active comparator | Device: Conventional nasal oxygen therapy (COT), Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy, Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case. |
| High-flow nasal cannula (HFNC) group (35 patients) | Active comparator | Device: High-flow nasal cannula (HFNC), Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy, Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)Who will receive 30 L/min oxygen flow through VapothermR Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4, temperature at 37◦C with 100% humidity. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both males and females with age 20-60 years
- American Society of Anesthesiologists (ASA) class I, II or III
- Patients will undergo UGI endoscopic procedure with anticipated procedure time of over 15 minutes because of complexity of the procedure or recurrence, as assessed by the consultant gastroenterologist responsible for the case
Key exclusion criteria (8 listed)
- Patient refusal or propofol allergy history.
- Suspected difficult airway or Mallampati score more than 3
- Body mass index (BMI) more than 35 kg/m2 (weight will be measured in kilograms and height in meters,then BMI will be measured by equation where: BMI=weight(Kg) / height square (m2))
- Pregnant patients
- Respiratory compromise as patients dependent on supplemental oxygen including respiratory failure or with active chest condition e.g. bronchial asthma or pneumonia
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 |
|---|---|---|
| High-flow nasal cannula (HFNC)Also: Vapotherm Precision Flow HI-VNI Technology devicehigh flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39◦ C, humidity minimum of 12mg/liter) | Device | High-flow nasal cannula (HFNC) group (35 patients) |
| Conventional nasal oxygen therapy (COT)Also: UltramedAdult size, single use nasal cannula | Device | Conventional nasal oxygen therapy (COT) group (35 patients) |
| Upper gastrointestinal endoscopy (UGE) including gastroscopyAlso: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).Upper gastrointestinal endoscopy (UGE) will be either diagnostic and/or therapeutic including variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation. | Device | Conventional nasal oxygen therapy (COT) group (35 patients), High-flow nasal cannula (HFNC) group (35 patients) |
| Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)Also: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).Upper gastrointestinal endoscopy (UGE) will be diagnostic | Device | Conventional nasal oxygen therapy (COT) group (35 patients), High-flow nasal cannula (HFNC) group (35 patients) |
Primary outcome
Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure.
Time frame: During the procedure.
moderate hypoxemia, defined as SpO2 < 90%
6 secondary outcomes
The median lowest SpO2
Time frame: During the procedure
Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes
Time frame: During the procedure
Clinically significant hypoxia
Time frame: During the procedure
Sedation related adverse effects (SRAEs)
Time frame: During the procedure and immediately after the procedure for 6 hours
Procedure-related adverse events (PRAEs)
Time frame: During the procedure and immediately after the procedure for 24 hours
Propofol total used doses in milligrams (mgs)
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 40110237Mohamed AM, Selima WZ. HFNC Oxygen Therapy vs COT in Prolonged Upper Gastrointestinal Endoscopy Inside the ICU: A Prospective, Randomized, Controlled Clinical Study. Indian J Crit Care Med. 2025 Mar;29(3):223-229. doi: 10.5005/jp-journals-10071-24919. Epub 2025 Feb 28.
- Individual participant dataSharing planned: No. The statistics methods and results data will be shared after completing the study
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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.
Ahmed M Mohamed, MD principal investigator
Ain Shames University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula (HFNC), Conventional nasal oxygen therapy (COT) and Upper gastrointestinal endoscopy (UGE) including gastroscopy in people with Upper Gastrointestinal Bleeding, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 8 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 29 Oct 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure. (time frame: During the procedure.). 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 NCT06350864, which also lists 1 linked publication.
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 29 Oct 2024.