Superior Laryngeal Nerve BlockNCT07397234
Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation
A study testing Ultrasound-guided bilateral Thyroid Cartilage Plane Block and Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block in people with Superior Laryngeal Nerve Block, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Superior Laryngeal Nerve Block
- What is being tested?
- Ultrasound-guided bilateral Thyroid Cartilage Plane Block and Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesChina
- Study dates
- 11 Feb 2026to 1 Sep 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for awake tracheal intubation under general anesthesia.
- Patients with difficult airways (e.g., limited cervical spine mobility, full stomach, partial airway obstruction, craniofacial deformities or trauma, micrognathia, mouth opening <3cm, Mallampati III or IV classification) posing challenges for mask ventilation or intubation.
- Age between 18 and 85 years old.
- Gender is not restricted.
- ASA classification of I - III.
Who cannot join
- Cardiovascular dysfunction or arterial aneurysms.
- Mental or neurological disorders or concomitant arterial aneurysms.
- Infection at the puncture site.
- Allergy to local anesthetics.
- Continuous use of antiplatelet or anticoagulant medications preoperatively.
- Hoarseness or coughing while drinking water.
- Bronchial asthma.
- Participation in other clinical trials within the previous 3 months before enrollment 9.r current participation in other clinical trials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Completed
Nanjing First Hospital
Nanjing, Jiangsu, 210006
- Recruiting
Nanjing First Hospital
Nanjing, 210006
Tao Shan, PhD, 18852095135, shantao2021@163.com
About this study
Official title: Thyroid Cartilage Plane Versus Superior Laryngeal Nerve Space for Ultrasound-guided Superior Laryngeal Nerve Block in Awake Tracheal Intubation: a Randomised Non-inferiority Clinical Trial
The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Patients were randomized into the thyroid cartilage plane block group (T group) or the superior laryngeal nerve space block group (C group). In Group T, bilateral thyroid cartilage plane block was performed under ultrasound with thyroid cartilage as the landmark, and local anesthetic was injected on the surface of the thyroid cartilage. In Group C, local anesthetic was injected into the space between the thyrohyoid membrane and muscle groups above.
The investigators aim to evaluate whether the thyroid cartilage plane approach is not inferior to the superior laryngeal nerve space approach for ultrasound-guided superior laryngeal nerve block in awake tracheal intubation
Read the detailed description
After entering the operation room, ECG, SPO2, and invasive blood pressure were monitored. Sedation was facilitated. The proper anaesthesia depth was maintained at 60-80 using the bispectral index. Additionally, 0.5 mg of Penehyclidine Hydrochloride was injected intravenously once the venous access was established. 100% oxygen 4 L min-1 was administered with a nasal cannula throughout the procedure. All patients received topical pharyngeal anesthesia using lidocaine spray. The investigators used a 5-12 MHz linear probeto perform bilateral block. The probe was placed parasagittally to locate the thyroid cartilage and superior laryngeal nerve space. After identification of related structure, the investigators advanced a 22-gauge needle medial to the transducer at the upper half of the thyroid cartilage laminae until it touched the laminae or superior laryngeal nerve space using the out-of-plane technique. The correct location of the needle tip in the fascial deep to the muscle groups was confirmed by injecting 0.5-1 ml saline. A total of 2% lidocaine 2.5 ml was administered after negative aspiration bilaterally. "Spray-as-you-go" technique guided by a fiberoptic bronchoscope was performed to the tracheal with 5 ml of 2% lidocaine. After airway anesthesia, intubation completed.
The primary outcome was the proportion of acceptable intubation conditions (AIC). Secondary outcomes were the performance time, Ramsay sedation score, the patient's cough condition, comfort score, and tracheal tube tolerance score and other perioperative complications including airway hemorrhage and superior laryngeal nerve damage.
- Conditions
- Superior Laryngeal Nerve Block
- Being tested
- Ultrasound-guided bilateral Thyroid Cartilage Plane Block, Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block
- Keywords
- Thyroid Cartilage plane, Superior laryngeal nerve space, Difficult airway, Superior Laryngeal Nerve, Awake tracheal intubation, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided bilateral Thyroid Cartilage Plane BlockProcedure or surgery
Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. Once the needle tip contacts the cranial half of the thyroid cartilage, injecting 2.5ml of 2% lidocaine on the surface of the thyroid cartilage each side.
Ultrasound-guided bilateral Superior Laryngeal Nerve Space BlockProcedure or surgery
Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the superior laryngeal nerve space under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. 2% lidocaine 2.5ml was injected into the space between the thyrohyoid membrane and muscle groups above.
| Study group | Role | What they receive |
|---|---|---|
| Superior Laryngeal Nerve Space Block Group (C Group) | Active comparator | All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Under ultrasound guidance, the needle was advanced step by step into the potential space between the relevant muscle groups and the thyrohyoid membrane. When the needle tip contacted the surface of the thyrohyoid membrane and slightly penetrated the submembranous tissue, negative aspiration was confirmed, and 2.5 mL of 2% lidocaine was injected into the space on each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation. Receives: Procedure: Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block |
| Thyroid Cartilage Plane Block Group (T Group) | Experimental | All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 2% lidocaine 5ml. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation. Receives: Procedure: Ultrasound-guided bilateral Thyroid Cartilage Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with acceptable intubation conditions (AIC)
The evaluation of the intubation condition was based on the Cormack-Lehane classification, vocal cord movement, 5-point reaction scale, and severity of coughing.
Clinically, AIC was defined when each part was scaled to Grade 1 or Grade 2. The proportion of AIC = number of participants with AIC/number of participants who received ATI in each group.
Measured: Upon intubation
Secondary outcomes (12)
Quality of airway anesthesia
The quality of airway anesthesia assessed on a 5-point scale,Quality of airwayanesthesia was graded as: 0=no coughing or gagging in response to intubation, 1=mild coughing and/or gaggingthat did not hinder intubation, 2=moderate coughing and/or gagging that interfered minimally with intubation,3=severe coughing and/or gagging that made intubation difficult and 4=very severe coughing and/or gaggingthat required additional local anesthetic and/or change in technique.The lower grade means a better quality of airway anesthesia.
Measured: Upon intubation
Mean Arterial Pressure
Stable blood pressure indicates a good neural blockade effect.
Measured: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Heart Rate
Time Frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediatelyafter tracheal tube insertion,T3: 5 minutes after successful intubation
Measured: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Ramsay Sedation Score
The Ramsay Sedation Score is as follows: 6 points for unarousable, 5 points for slow response to stimulus, 4points for asleep but easily aroused, 3 points for quiet and cooperative with orientation, 2 points for asleep,anxious, restless, and 1 point for asleep, agitated, and restless. Satisfactory sedation falls within 2-4 points,while oversedation is indicated by 5-6 points.
Measured: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
The number of patients with lowered pitch
A lowered pitch might indicate a good neural blockade effect.
Measured: Before intubation
The time needed for blockade procedure
The neural blockade procedure time reflects the ease of the operation, with a shorter time indicating a simpler neural blockade procedure.
Measured: From ultrasounography localization to completion of local anesthetic administration
Record coughing in patients when the fiberoptic bronchoscope touches the glottis
The patient's coughing upon contact of the fiberoptic bronchoscope with the vocal cords before intubation reflects the effectiveness of neural blockade. A lower degree of coughing indicates a better neural blockadeeffect. 1 point for no response, 2 points for mild cough, 3 points for severe cough.
Measured: Before intubation
The tolerance score after the tube insertion
The tolerance of the tube reflects the patient's tolerance to awake tracheal intubation. A higher score indicates a better outcome. 3 points for severe resistance requiring immediate general anesthesia, 2 points for restlessness and mild resistance, 1 point for cooperation.
Measured: Five minutes after successful intubation
Adverse reactions such as coughing and nausea/vomiting
The lower the incidence of coughing, nausea, and vomiting, the better the neural blockade effect.
Measured: During intubation
Occurrences of sore throat and lowered pitch
Pharyngeal pain and decreased vocal tone are used to assess postoperative complications of neural blockade.
Measured: Post-extubation,24 hours after surgery
Total procedure time needed for awake intubation
The total procedure time reflects the ease of the operation, with a shorter time indicating a simpler procedure.
Measured: From the initiation of topical anesthesia to the accomplishment of tracheal intubation
Airway hemorrhage or nerve damage
Observation of bleeding of the laryngeal mucosa via fiberoptic bronchoscope or observation of bloody secretions via coughing or suction
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 Feb 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Laryngeal Nerve BlockStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Shan, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Tao Shan, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397234
- Sponsor's protocol ID
- KY20260108-04
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Cartilage Plane Versus Superior Laryngeal Nerve Space for Ultrasound-guided Superior Laryngeal Nerve Block in Awake Tracheal Intubation: a Randomised Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT07397234
- Acronym / sponsor ID
- KY20260108-04
- Conditions
- Superior Laryngeal Nerve Block
- Keywords
- Thyroid Cartilage plane, Superior laryngeal nerve space, Difficult airway, Superior Laryngeal Nerve, Awake tracheal intubation, Nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 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.
The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Patients were randomized into the thyroid cartilage plane block group (T group) or the superior laryngeal nerve space block group (C group). In Group T, bilateral thyroid cartilage plane block was performed under ultrasound with thyroid cartilage as the landmark, and local anesthetic was injected on the surface of the thyroid cartilage. In Group C, local anesthetic was injected into the space between the thyrohyoid membrane and muscle groups above.
The investigators aim to evaluate whether the thyroid cartilage plane approach is not inferior to the superior laryngeal nerve space approach for ultrasound-guided superior laryngeal nerve block in awake tracheal intubation
Detailed description
After entering the operation room, ECG, SPO2, and invasive blood pressure were monitored. Sedation was facilitated. The proper anaesthesia depth was maintained at 60-80 using the bispectral index. Additionally, 0.5 mg of Penehyclidine Hydrochloride was injected intravenously once the venous access was established. 100% oxygen 4 L min-1 was administered with a nasal cannula throughout the procedure. All patients received topical pharyngeal anesthesia using lidocaine spray. The investigators used a 5-12 MHz linear probeto perform bilateral block. The probe was placed parasagittally to locate the thyroid cartilage and superior laryngeal nerve space. After identification of related structure, the investigators advanced a 22-gauge needle medial to the transducer at the upper half of the thyroid cartilage laminae until it touched the laminae or superior laryngeal nerve space using the out-of-plane technique. The correct location of the needle tip in the fascial deep to the muscle groups was confirmed by injecting 0.5-1 ml saline. A total of 2% lidocaine 2.5 ml was administered after negative aspiration bilaterally. "Spray-as-you-go" technique guided by a fiberoptic bronchoscope was performed to the tracheal with 5 ml of 2% lidocaine. After airway anesthesia, intubation completed.
The primary outcome was the proportion of acceptable intubation conditions (AIC). Secondary outcomes were the performance time, Ramsay sedation score, the patient's cough condition, comfort score, and tracheal tube tolerance score and other perioperative complications including airway hemorrhage and superior laryngeal nerve damage.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior Laryngeal Nerve Space Block Group (C Group) | Active comparator | Procedure: Ultrasound-guided bilateral Superior Laryngeal Nerve Space BlockAll patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Under ultrasound guidance, the needle was advanced step by step into the potential space between the relevant muscle groups and the thyrohyoid membrane. When the needle tip contacted the surface of the thyrohyoid membrane and slightly penetrated the submembranous tissue, negative aspiration was confirmed, and 2.5 mL of 2% lidocaine was injected into the space on each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation. |
| Thyroid Cartilage Plane Block Group (T Group) | Experimental | Procedure: Ultrasound-guided bilateral Thyroid Cartilage Plane BlockAll patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 2% lidocaine 5ml. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for awake tracheal intubation under general anesthesia.
- Patients with difficult airways (e.g., limited cervical spine mobility, full stomach, partial airway obstruction, craniofacial deformities or trauma, micrognathia, mouth opening <3cm, Mallampati III or IV classification) posing challenges for mask ventilation or intubation.
- Age between 18 and 85 years old.
- Gender is not restricted.
- ASA classification of I - III.
Key exclusion criteria (8 listed)
- Cardiovascular dysfunction or arterial aneurysms.
- Mental or neurological disorders or concomitant arterial aneurysms.
- Infection at the puncture site.
- Allergy to local anesthetics.
- Continuous use of antiplatelet or anticoagulant medications preoperatively.
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 |
|---|---|---|
| Ultrasound-guided bilateral Thyroid Cartilage Plane BlockUse a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. Once the needle tip contacts the cranial half of the thyroid cartilage, injecting 2.5ml of 2% lidocaine on the surface of the thyroid cartilage each side. | Procedure or surgery | Thyroid Cartilage Plane Block Group (T Group) |
| Ultrasound-guided bilateral Superior Laryngeal Nerve Space BlockUse a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the superior laryngeal nerve space under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. 2% lidocaine 2.5ml was injected into the space between the thyrohyoid membrane and muscle groups above. | Procedure or surgery | Superior Laryngeal Nerve Space Block Group (C Group) |
Primary outcome
The proportion of patients with acceptable intubation conditions (AIC)
Time frame: Upon intubation
The evaluation of the intubation condition was based on the Cormack-Lehane classification, vocal cord movement, 5-point reaction scale, and severity of coughing. Clinically, AIC was defined when each part was scaled to Grade 1 or Grade 2. The proportion of AIC = number of participants with AIC/number of participants who received ATI in each group.
12 secondary outcomes
Quality of airway anesthesia
Time frame: Upon intubation
Mean Arterial Pressure
Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Heart Rate
Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Ramsay Sedation Score
Time frame: T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
The number of patients with lowered pitch
Time frame: Before intubation
The time needed for blockade procedure
Time frame: From ultrasounography localization to completion of local anesthetic administration
Record coughing in patients when the fiberoptic bronchoscope touches the glottis
Time frame: Before intubation
The tolerance score after the tube insertion
Time frame: Five minutes after successful intubation
Adverse reactions such as coughing and nausea/vomiting
Time frame: During intubation
Occurrences of sore throat and lowered pitch
Time frame: Post-extubation,24 hours after surgery
Total procedure time needed for awake intubation
Time frame: From the initiation of topical anesthesia to the accomplishment of tracheal intubation
Airway hemorrhage or nerve damage
Time frame: During intubation
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 28 Jul 2026.
- 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.
Tao Shan principal investigator
Nanjing First Hospital, Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided bilateral Thyroid Cartilage Plane Block and Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block in people with Superior Laryngeal Nerve Block, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
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 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Tao Shan (+8618852095135, 858727933@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with acceptable intubation conditions (AIC) (time frame: Upon intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.