Safety and EfficacyNCT05556889
Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block
A study testing a modified auriculotemporal nerve blockade and Traditional auriculotemporal nerve blockade in people with Safety and Efficacy and Scalp Nerve Block, run by Tongji Hospital at 1 site in China.
Trial summary
1. Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy 2. Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Safety and Efficacy, Scalp Nerve Block
- What is being tested?
- a modified auriculotemporal nerve blockade and Traditional auriculotemporal nerve blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing supratentorial craniotomy under general anesthesia;
- 18-65 years old;
- ASA I or II.
Who cannot join
- Emergency surgery;
- Be allergic to ropivacaine;
- Participating in other clinical investigation within 30 days;
- Skin infection at the puncture site;
- Patients taking analgesic drugs before surgery;
- Persons addicted to alcohol or drugs;
Show all 12Show fewer
- Patients with severe liver and kidney dysfunction;
- Patients with coagulation disorder;
- Pregnant and lactating women;
- Patients with consciousness disorder before surgery;
- Those who have undergone neurosurgery within the last 6 months;
- Patients who were unable to understand the NRS before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Gao Feng, Doctor, 13971587381 ext. 86, fgao@tjh.tjmu.edu.cn
About this study
Official title: Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block: a Prospective, Randomized, Double-blind, Traditional Controlled Study
- Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
- Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
Read the detailed description
Scalp nerve block for supratentorial craniotomy patients can effectively reduce the consumption of perioperative analgesic drugs, avoid the occurrence of hypertension and tachycardia, relieve postoperative pain, improve postoperative recovery quality of patients. Scalp nerve block is safe and has fewer complications due to the small amount of local anesthetic. For auriculotemporal nerve block, temporary block of adjacent facial nerve is one of the most likely complications, with an incidence of 8.6%, and usually can be recovered within 24 hours, since the facial nerve was located in the anterior and lower part of the tragus, 1 cm deep in the skin. Therefore, improving nerve block methods and reducing the dosage of local anesthetics may reduce the risk of facial nerve block. The investigators proposed helix feet in front of the zygomatic arch as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. The study intends to compare a modified auriculotemporal nerve block method with the traditional way, reflecting on perioperative hemodynamical fluctuation, postoperative analgesia effect and incidence of facial nerve paralysis. This will verify the safety and analgesic efficacy of the modified nerve block method proposed in this study, and then provide a basis for improving the quality of perioperative management during neurosurgery.
- Conditions
- Safety and Efficacy, Scalp Nerve Block
- Being tested
- a modified auriculotemporal nerve blockade, Traditional auriculotemporal nerve blockade
- Keywords
- Auriculotemporal nerve block, Scalp nerve block, safety and efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a modified auriculotemporal nerve blockadeProcedure or surgery
Helix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood.
Traditional auriculotemporal nerve blockadeProcedure or surgery
Traditional auriculotemporal nerve blockade
| Study group | Role | What they receive |
|---|---|---|
| a modified auriculotemporal nerve blockade | Experimental | Helix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. Receives: Procedure: a modified auriculotemporal nerve blockade |
| Traditional auriculotemporal nerve blockade | Other | The traditional method of auriculotemporal nerve block is to inject the needle 1~1.5 cm vertically at the level of tragus and posterior of superficial temporal artery, and inject 2-3 ml of local anesthetics after pumping back without blood Receives: Procedure: Traditional auriculotemporal nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS) score in both groups 2 hours after surgery
2 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 2 hours after supratentorial craniotomy
numerical rating scale (NRS) score in both groups 8 hours after surgery
8 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 8 hours after supratentorial craniotomy
numerical rating scale (NRS) score in both groups 24 hours after surgery
24 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
Measured: 24 hours after supratentorial craniotomy
incidence of facial paralysis in both two groups
within 24 hours after supratentorial craniotomy, the investigators evaluate facial nerve function of awakened participants (Diagnostic criteria for facial paralysis: unable to raise the eyebrows on the same side, unable to frown, unable to close eyes completely, or unable to smile due to facial paralysis on the same side), and record the number of patients who suffer from facial paralysis, and then calculate the incidence as: the number of patient suffering from facial paralysis/the total number in corresponding group
Measured: within 24 hours after supratentorial craniotomy
Secondary outcomes (32)
mean arterial pressure (MAP) before anesthesia induction
MAP before anesthesia induction
Measured: before anesthesia induction
heart rate (HR) before anesthesia induction
HR before anesthesia induction
Measured: before anesthesia induction
MAP 3 minutes after tracheal intubation
MAP 3 minutes after tracheal intubation
Measured: 3 minutes after tracheal intubation
HR 3 minutes after tracheal intubation
HR 3 minutes after tracheal intubation
Measured: 3 minutes after tracheal intubation
MAP before nerve block
MAP before nerve block
Measured: before nerve block
HR before nerve block
HR before nerve block
Measured: before nerve block
MAP within 10 minutes after nerve block
MAP within 10 minutes after nerve block
Measured: within 10 minutes after nerve block
HR within 10 minutes after nerve block
HR within 10 minutes after nerve block
Measured: within 10 minutes after nerve block
MAP 1 minute after temporal region skin incision
MAP 1 minute after temporal region skin incision
Measured: 1 minute after temporal region skin incision
HR 1 minute after temporal region skin incision
HR 1 minute after temporal region skin incision
Measured: 1 minute after temporal region skin incision
MAP 2 minutes after temporal region skin incision
MAP 2 minutes after temporal region skin incision
Measured: 2 minutes after temporal region skin incision
HR 2 minutes after temporal region skin incision
HR 2 minutes after temporal region skin incision
Measured: 2 minutes after temporal region skin incision
MAP 3 minutes after temporal region skin incision
MAP 3 minutes after temporal region skin incision
Measured: 3 minutes after temporal region skin incision
HR 3 minutes after temporal region skin incision
HR 3 minutes after temporal region skin incision
Measured: 3 minutes after temporal region skin incision
MAP 4 minutes after temporal region skin incision
MAP 4 minutes after temporal region skin incision
Measured: 4 minutes after temporal region skin incision
HR 4 minutes after temporal region skin incision
HR 4 minutes after temporal region skin incision
Measured: 4 minutes after temporal region skin incision
MAP 5 minutes after temporal region skin incision
MAP 5 minutes after temporal region skin incision
Measured: 5 minutes after temporal region skin incision
HR 5 minutes after temporal region skin incision
HR 5 minutes after temporal region skin incision
Measured: 5 minutes after temporal region skin incision
MAP 10 minutes after temporal region skin incision
MAP 10 minutes after temporal region skin incision
Measured: 10 minutes after temporal region skin incision
HR 10 minutes after temporal region skin incision
HR 10 minutes after temporal region skin incision
Measured: 10 minutes after temporal region skin incision
MAP 20 minutes after temporal region skin incision
MAP 20 minutes after temporal region skin incision
Measured: 20 minutes after temporal region skin incision
HR 20 minutes after temporal region skin incision
HR 20 minutes after temporal region skin incision
Measured: 20 minutes after temporal region skin incision
MAP 30 minutes after temporal region skin incision
MAP 30 minutes after temporal region skin incision
Measured: 30 minutes after temporal region skin incision
HR 30 minutes after temporal region skin incision
HR 30 minutes after temporal region skin incision
Measured: 30 minutes after temporal region skin incision
MAP 40 minutes after temporal region skin incision
MAP 40 minutes after temporal region skin incision
Measured: 40 minutes after temporal region skin incision
HR 40 minutes after temporal region skin incision
HR 40 minutes after temporal region skin incision
Measured: 40 minutes after temporal region skin incision
MAP 50 minutes after temporal region skin incision
MAP 50 minutes after temporal region skin incision
Measured: 50 minutes after temporal region skin incision
HR 50 minutes after temporal region skin incision
HR 50 minutes after temporal region skin incision
Measured: 50 minutes after temporal region skin incision
MAP 1 hour after temporal region skin incision
MAP 1 hour after temporal region skin incision
Measured: 1 hour after temporal region skin incision
HR 1 hour after temporal region skin incision
HR 1 hour after temporal region skin incision
Measured: 1 hour after temporal region skin incision
MAP during surgery (at tracheal extubation)
MAP during surgery (at tracheal extubation)
Measured: during surgery (at tracheal extubation)
HR during surgery (at tracheal extubation)
HR during surgery (at tracheal extubation)
Measured: during surgery (at tracheal extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EfficacyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
- Investigators
- feng gao, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556889
- Sponsor's protocol ID
- TJ2021S195
- Status last verified
- May 2024
- First submitted
- 30 Mar 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block: a Prospective, Randomized, Double-blind, Traditional Controlled Study
- ClinicalTrials.gov ID
- NCT05556889
- Acronym / sponsor ID
- TJ2021S195
- Conditions
- Safety and Efficacy, Scalp Nerve Block
- Keywords
- Auriculotemporal nerve block, Scalp nerve block, safety and efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
- Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
- Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
Detailed description
Scalp nerve block for supratentorial craniotomy patients can effectively reduce the consumption of perioperative analgesic drugs, avoid the occurrence of hypertension and tachycardia, relieve postoperative pain, improve postoperative recovery quality of patients. Scalp nerve block is safe and has fewer complications due to the small amount of local anesthetic. For auriculotemporal nerve block, temporary block of adjacent facial nerve is one of the most likely complications, with an incidence of 8.6%, and usually can be recovered within 24 hours, since the facial nerve was located in the anterior and lower part of the tragus, 1 cm deep in the skin. Therefore, improving nerve block methods and reducing the dosage of local anesthetics may reduce the risk of facial nerve block. The investigators proposed helix feet in front of the zygomatic arch as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. The study intends to compare a modified auriculotemporal nerve block method with the traditional way, reflecting on perioperative hemodynamical fluctuation, postoperative analgesia effect and incidence of facial nerve paralysis. This will verify the safety and analgesic efficacy of the modified nerve block method proposed in this study, and then provide a basis for improving the quality of perioperative management during neurosurgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a modified auriculotemporal nerve blockade | Experimental | Procedure: a modified auriculotemporal nerve blockadeHelix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. |
| Traditional auriculotemporal nerve blockade | Other | Procedure: Traditional auriculotemporal nerve blockadeThe traditional method of auriculotemporal nerve block is to inject the needle 1~1.5 cm vertically at the level of tragus and posterior of superficial temporal artery, and inject 2-3 ml of local anesthetics after pumping back without blood |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing supratentorial craniotomy under general anesthesia;
- 18-65 years old;
- ASA I or II.
Key exclusion criteria (12 listed)
- Emergency surgery;
- Be allergic to ropivacaine;
- Participating in other clinical investigation within 30 days;
- Skin infection at the puncture site;
- Patients taking analgesic drugs before surgery;
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 |
|---|---|---|
| a modified auriculotemporal nerve blockadeHelix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. | Procedure or surgery | a modified auriculotemporal nerve blockade |
| Traditional auriculotemporal nerve blockadeTraditional auriculotemporal nerve blockade | Procedure or surgery | Traditional auriculotemporal nerve blockade |
Primary outcome
numerical rating scale (NRS) score in both groups 2 hours after surgery
Time frame: 2 hours after supratentorial craniotomy
2 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
numerical rating scale (NRS) score in both groups 8 hours after surgery
Time frame: 8 hours after supratentorial craniotomy
8 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
numerical rating scale (NRS) score in both groups 24 hours after surgery
Time frame: 24 hours after supratentorial craniotomy
24 hours after supratentorial craniotomy, the participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method.
incidence of facial paralysis in both two groups
Time frame: within 24 hours after supratentorial craniotomy
within 24 hours after supratentorial craniotomy, the investigators evaluate facial nerve function of awakened participants (Diagnostic criteria for facial paralysis: unable to raise the eyebrows on the same side, unable to frown, unable to close eyes completely, or unable to smile due to facial paralysis on the same side), and record the number of patients who suffer from facial paralysis, and then calculate the incidence as: the number of patient suffering from facial paralysis/the total number in corresponding group
32 secondary outcomes
mean arterial pressure (MAP) before anesthesia induction
Time frame: before anesthesia induction
heart rate (HR) before anesthesia induction
Time frame: before anesthesia induction
MAP 3 minutes after tracheal intubation
Time frame: 3 minutes after tracheal intubation
HR 3 minutes after tracheal intubation
Time frame: 3 minutes after tracheal intubation
MAP before nerve block
Time frame: before nerve block
HR before nerve block
Time frame: before nerve block
MAP within 10 minutes after nerve block
Time frame: within 10 minutes after nerve block
HR within 10 minutes after nerve block
Time frame: within 10 minutes after nerve block
MAP 1 minute after temporal region skin incision
Time frame: 1 minute after temporal region skin incision
HR 1 minute after temporal region skin incision
Time frame: 1 minute after temporal region skin incision
MAP 2 minutes after temporal region skin incision
Time frame: 2 minutes after temporal region skin incision
HR 2 minutes after temporal region skin incision
Time frame: 2 minutes after temporal region skin incision
MAP 3 minutes after temporal region skin incision
Time frame: 3 minutes after temporal region skin incision
HR 3 minutes after temporal region skin incision
Time frame: 3 minutes after temporal region skin incision
MAP 4 minutes after temporal region skin incision
Time frame: 4 minutes after temporal region skin incision
HR 4 minutes after temporal region skin incision
Time frame: 4 minutes after temporal region skin incision
MAP 5 minutes after temporal region skin incision
Time frame: 5 minutes after temporal region skin incision
HR 5 minutes after temporal region skin incision
Time frame: 5 minutes after temporal region skin incision
MAP 10 minutes after temporal region skin incision
Time frame: 10 minutes after temporal region skin incision
HR 10 minutes after temporal region skin incision
Time frame: 10 minutes after temporal region skin incision
MAP 20 minutes after temporal region skin incision
Time frame: 20 minutes after temporal region skin incision
HR 20 minutes after temporal region skin incision
Time frame: 20 minutes after temporal region skin incision
MAP 30 minutes after temporal region skin incision
Time frame: 30 minutes after temporal region skin incision
HR 30 minutes after temporal region skin incision
Time frame: 30 minutes after temporal region skin incision
MAP 40 minutes after temporal region skin incision
Time frame: 40 minutes after temporal region skin incision
HR 40 minutes after temporal region skin incision
Time frame: 40 minutes after temporal region skin incision
MAP 50 minutes after temporal region skin incision
Time frame: 50 minutes after temporal region skin incision
HR 50 minutes after temporal region skin incision
Time frame: 50 minutes after temporal region skin incision
MAP 1 hour after temporal region skin incision
Time frame: 1 hour after temporal region skin incision
HR 1 hour after temporal region skin incision
Time frame: 1 hour after temporal region skin incision
MAP during surgery (at tracheal extubation)
Time frame: during surgery (at tracheal extubation)
HR during surgery (at tracheal extubation)
Time frame: during surgery (at tracheal extubation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
Related trials for Safety and Efficacy
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Active, not recruiting
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Skin Resurfacing
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.
feng gao principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a modified auriculotemporal nerve blockade and Traditional auriculotemporal nerve blockade in people with Safety and Efficacy and Scalp Nerve Block, run by Tongji Hospital at 1 site 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao (13971587381 ext. 86, fgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale (NRS) score in both groups 2 hours after surgery (time frame: 2 hours after supratentorial craniotomy). The study lists 4 primary outcomes in all. 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 31 May 2024.