This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local AnesthesiaNCT07426523
Effectiveness of Needle-Free Infiltration Anesthesia in Reduction of Dental Pain and Anxiety During Local Anesthesia.
A study testing INJEX 30 and Traditional syringe in people with This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia, run by Damascus University at 1 site in Syria.
Trial summary
Local anesthesia is a common and essential procedure for the majority of dental treatments. The most frequently used method of administration is needle injection. Although this technique effectively controls pain, the sight of the needle and the pain experienced during injection often cause fear and anxiety… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia
- What is being tested?
- INJEX 30 and Traditional syringe
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSyria
- Study dates
- 28 May 2025to 26 Nov 2025
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-9 years with no previous dental experience.
- Children classified as positive or definitely positive according to the Frankl behavior rating scale.
- Children requiring local anesthesia in the lower primary molar region for therapeutic dental procedures
Who cannot join
- Children with systemic diseases that contraindicate the administration of local anesthesia or the required dental treatment.
- Children who have received sedative or analgesic medications within the 3 hours preceding the dental visit
- -
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Pediatric Dentistry, Faculty of Dentistry
Damascus, Rif-dimashq Governorate
About this study
Official title: Evaluation of the Effectiveness of Needle-Free Infiltration Anesthesia in Alleviating Dental Pain and Anxiety Among Children During Local Anesthesia. Randomized Controlled Trial
Local anesthesia is a common and essential procedure for the majority of dental treatments. The most frequently used method of administration is needle injection. Although this technique effectively controls pain, the sight of the needle and the pain experienced during injection often cause fear and anxiety, especially in children. This can lead to negative attitudes toward dental treatment, highlighting the need for less painful alternatives for delivering local anesthesia.
This randomized clinical trial aimed to evaluate the effectiveness of the needle-free INJEX 30 device in reducing pain and anxiety in children aged 6 to 9 years.
Read more
Eligible children requiring local anesthesia in the mandibular primary molar region for therapeutic dental procedures were randomly assigned to two groups according to the type of injection system used (INJEX or conventional syringe).
Immediately after the administration of local anesthesia, anxiety was assessed using a physiological measure (plus rate), and pain was evaluated using a self-reported scale (Wong-Baker Faces Pain Scale). Pain was also assessed using a non-self-reported behavioral scale (FLACC) based on video recordings taken during anesthesia administration.
The findings of this study provide clinical evidence about the effectiveness of the INJEX device in reducing pain and anxiety during local anesthesia in pediatric dental patients, which thereby improving clinical decision-making and enhancing the quality of dental care for children.
Read the detailed description
Local anesthesia is a cornerstone of pediatric dental treatment, allowing clinicians to perform restorative and preventive procedures while minimizing pain and discomfort. Nevertheless, administering local anesthesia in children presents several challenges. Achieving profound anesthesia can be difficult in some cases due to anatomical variations, while the risk of local anesthetic toxicity is increased because of the child's lower body weight. Most importantly, fear of needles and pain during injection often provoke anxiety and unpredictable behavioral responses, which can complicate dental treatment and negatively affect the child's overall experience.
The inferior alveolar nerve block is commonly used for pulp therapy of lower primary molars, as it provides relatively deep and long-lasting anesthesia. However, this technique is associated with several disadvantages, including a higher risk of soft tissue injury, prolonged numbness, and greater discomfort during injection. Additionally, inferior alveolar nerve block injections are generally perceived as more painful than infiltration anesthesia techniques, particularly in pediatric patients.
Despite the effectiveness of conventional nerve block techniques, their limitations in children highlight the need for alternative anesthesia methods that are less painful while maintaining adequate anesthetic efficacy. Therefore, a different anesthetic approach with a shorter duration but comparable effectiveness was considered. For this purpose, a needle-free, pressure-based injection system was used in the present study.
Needleless injection devices, such as the INJEX system, deliver local anesthetic solutions into the tissues using high pressure, eliminating the need for conventional needles.
This study aimed to evaluate and compared the effectiveness of the INJEX device and the conventional syringe technique in administering local anesthesia for lower primary molars, with a particular focus on pain perception and anxiety reduction. Both subjective pain assessment scales and objective physiological and behavioral measures were employed to provide a comprehensive evaluation. By identifying anesthetic techniques that reduce pain and anxiety while maintaining clinical effectiveness, this research seeked to improve the quality of pediatric dental care and promote more positive dental experiences for children
- Conditions
- This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia
- Being tested
- INJEX 30, Traditional syringe
- Keywords
- Dental Pain and anxiety, Local anesthesia, Infiltration anesthesia, Needle-free anesthesia
- Medical subject headings
- Toothache, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INJEX 30Device
Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group.
The dental procedure was then explained to the child using the "Tell-Show-Do" technique. A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia.
- group: 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administered locally by infiltration using the INJEX 30 device.
- group :1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidocaine will be administered using a conventional syringe as an inferior alveolar nerve block.
Traditional syringeProcedure or surgery
After obtaining the general medical history of each child, comprehensive clinical and radiographic examinations were performed to assess the feasibility of performing dental procedures in the lower primary molar region under local anesthesia. Written informed consent was obtained from the parents or legal guardians for both the dental procedure and the child's participation in the study.
Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group.
Prior to the procedure, the child's pulse was measured using a physiological monitor (Plus Oximeter). The dental procedure was then explained to the child using the "Tell-Show-Do" technique.
A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia.
In this group, serving as the control, local anesthesia was administered using the conventional technique (inferior alveol
| Study group | Role | What they receive |
|---|---|---|
| 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administer | Experimental | Not described Receives: Device: INJEX 30 |
| 1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidoc | Active comparator | Not described Receives: Procedure: Traditional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Pain - FLACC Scale
Pain during local anesthesia administration will be evaluated using the FLACC behavioral observational scale (Face, Legs, Activity, Cry, Consolability). Scores range from 0-10:
0 = Relaxed 1-3 = Mild discomfort 4-6 = Moderate discomfort 7-10 = Severe discomfort Measurements will be recorded continuously during the administration of local anesthesia.
Measured: During local anesthesia administration, from insertion of the device into the oral cavity until completion of the anesthetic delivery and removal of the device.
Dental Pain - Wong-Baker Faces Scale
Pain will be self-assessed by the child using the Wong-Baker Faces Pain Rating Scale, consisting of six faces ranging from happiest (0 = no pain) to saddest (10 = severe pain). The child will be instructed to choose the face that best represents their pain immediately after local anesthesia administration.
Measured: Immediately after local anesthesia administration
Dental Anxiety - Pulse Rate
Dental anxiety will be estimated objectively by measuring pulse rate (beats per minute, bpm) using a pulse oximeter. Measurements will be taken at two time points:
- At baseline (pre-procedure, at set)
- Immediately after local anesthesia administration
Measured: Baseline and immediately after local anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start28 May 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426523
- Sponsor's protocol ID
- UDDS-Pedo-5-2025
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.
PubMed 20331333Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.
PubMed 31077857Kaya E, Yildirim S. Effect of a needle-free system versus traditional anesthesia on pain perception during palatal injections in children. Int J Paediatr Dent. 2023 Mar;33(2):132-140. doi: 10.1111/ipd.13028. Epub 2022 Oct 17.
PubMed 36151976Maganur PC, Vishwanathaiah S, Jafer MA, Moafa I, Alessa N, Assiry AA, Altowairqi SA, Basheri AAM, Najmi HH, Alhazmi ZA, Maafa SM, Jeevanandan G, Manoharan V. Pain and Anxiety Levels During Dental Restorations in Primary Molars: INJEX Needleless System vs Traditional Syringe. Med Sci Monit. 2025 Apr 18;31:e947691. doi: 10.12659/MSM.947691.
PubMed 40247611Patel M, Bhatt R, Mehta M, Patel C, Patel F, Makwani D. A comparative assessment of efficacy and preference between needleless device INJEX and insulin syringe for anesthetizing primary maxillary teeth in children aged 4-9 years: A split-mouth crossover randomized clinical study. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):149-155. doi: 10.4103/jisppd.jisppd_199_23.
PubMed 37635474Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.
PubMed 30673030
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Needle-Free Infiltration Anesthesia in Alleviating Dental Pain and Anxiety Among Children During Local Anesthesia. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07426523
- Acronym / sponsor ID
- UDDS-Pedo-5-2025
- Conditions
- This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia
- Keywords
- Dental Pain and anxiety, Local anesthesia, Infiltration anesthesia, Needle-free anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 23 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.
Local anesthesia is a common and essential procedure for the majority of dental treatments. The most frequently used method of administration is needle injection. Although this technique effectively controls pain, the sight of the needle and the pain experienced during injection often cause fear and anxiety, especially in children. This can lead to negative attitudes toward dental treatment, highlighting the need for less painful alternatives for delivering local anesthesia.
This randomized clinical trial aimed to evaluate the effectiveness of the needle-free INJEX 30 device in reducing pain and anxiety in children aged 6 to 9 years.
Eligible children requiring local anesthesia in the mandibular primary molar region for therapeutic dental procedures were randomly assigned to two groups according to the type of injection system used (INJEX or conventional syringe).
Immediately after the administration of local anesthesia, anxiety was assessed using a physiological measure (plus rate), and pain was evaluated using a self-reported scale (Wong-Baker Faces Pain Scale). Pain was also assessed using a non-self-reported behavioral scale (FLACC) based on video recordings taken during anesthesia administration.
The findings of this study provide clinical evidence about the effectiveness of the INJEX device in reducing pain and anxiety during local anesthesia in pediatric dental patients, which thereby improving clinical decision-making and enhancing the quality of dental care for children.
Detailed description
Local anesthesia is a cornerstone of pediatric dental treatment, allowing clinicians to perform restorative and preventive procedures while minimizing pain and discomfort. Nevertheless, administering local anesthesia in children presents several challenges. Achieving profound anesthesia can be difficult in some cases due to anatomical variations, while the risk of local anesthetic toxicity is increased because of the child's lower body weight. Most importantly, fear of needles and pain during injection often provoke anxiety and unpredictable behavioral responses, which can complicate dental treatment and negatively affect the child's overall experience.
The inferior alveolar nerve block is commonly used for pulp therapy of lower primary molars, as it provides relatively deep and long-lasting anesthesia. However, this technique is associated with several disadvantages, including a higher risk of soft tissue injury, prolonged numbness, and greater discomfort during injection. Additionally, inferior alveolar nerve block injections are generally perceived as more painful than infiltration anesthesia techniques, particularly in pediatric patients.
Despite the effectiveness of conventional nerve block techniques, their limitations in children highlight the need for alternative anesthesia methods that are less painful while maintaining adequate anesthetic efficacy. Therefore, a different anesthetic approach with a shorter duration but comparable effectiveness was considered. For this purpose, a needle-free, pressure-based injection system was used in the present study.
Needleless injection devices, such as the INJEX system, deliver local anesthetic solutions into the tissues using high pressure, eliminating the need for conventional needles.
This study aimed to evaluate and compared the effectiveness of the INJEX device and the conventional syringe technique in administering local anesthesia for lower primary molars, with a particular focus on pain perception and anxiety reduction. Both subjective pain assessment scales and objective physiological and behavioral measures were employed to provide a comprehensive evaluation. By identifying anesthetic techniques that reduce pain and anxiety while maintaining clinical effectiveness, this research seeked to improve the quality of pediatric dental care and promote more positive dental experiences for children
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administer | Experimental | Device: INJEX 30 |
| 1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidoc | Active comparator | Procedure: Traditional syringe |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-9 years with no previous dental experience.
- Children classified as positive or definitely positive according to the Frankl behavior rating scale.
- Children requiring local anesthesia in the lower primary molar region for therapeutic dental procedures
Key exclusion criteria (3 listed)
- Children with systemic diseases that contraindicate the administration of local anesthesia or the required dental treatment.
- Children who have received sedative or analgesic medications within the 3 hours preceding the dental visit
- -
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 |
|---|---|---|
| INJEX 30Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group. The dental procedure was then explained to the child using the "Tell-Show-Do" technique. A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia. 1. group: 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administered locally by infiltration using the INJEX 30 device. 2. group :1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidocaine will be administered using a conventional syringe as an inferior alveolar nerve block. | Device | 0.3 ml of lidocaine using injex: In the first group, 0.3 mL of lidocaine will be administer |
| Traditional syringeAfter obtaining the general medical history of each child, comprehensive clinical and radiographic examinations were performed to assess the feasibility of performing dental procedures in the lower primary molar region under local anesthesia. Written informed consent was obtained from the parents or legal guardians for both the dental procedure and the child's participation in the study. Participants were randomly assigned using the website (www.randomization.com), and based on the generated random numbers, each child was allocated to the corresponding study group. Prior to the procedure, the child's pulse was measured using a physiological monitor (Plus Oximeter). The dental procedure was then explained to the child using the "Tell-Show-Do" technique. A topical anesthetic gel (20% benzocaine) was applied at the injection site before administering local anesthesia. In this group, serving as the control, local anesthesia was administered using the conventional technique (inferior alveol | Procedure or surgery | 1.8 ml of lidocaine using Traditional syringe: In the second group (control group), 1.8 mL of lidoc |
Primary outcome
Dental Pain - FLACC Scale
Time frame: During local anesthesia administration, from insertion of the device into the oral cavity until completion of the anesthetic delivery and removal of the device.
Pain during local anesthesia administration will be evaluated using the FLACC behavioral observational scale (Face, Legs, Activity, Cry, Consolability). Scores range from 0-10: 0 = Relaxed 1-3 = Mild discomfort 4-6 = Moderate discomfort 7-10 = Severe discomfort Measurements will be recorded continuously during the administration of local anesthesia.
Dental Pain - Wong-Baker Faces Scale
Time frame: Immediately after local anesthesia administration
Pain will be self-assessed by the child using the Wong-Baker Faces Pain Rating Scale, consisting of six faces ranging from happiest (0 = no pain) to saddest (10 = severe pain). The child will be instructed to choose the face that best represents their pain immediately after local anesthesia administration.
Dental Anxiety - Pulse Rate
Time frame: Baseline and immediately after local anesthesia administration
Dental anxiety will be estimated objectively by measuring pulse rate (beats per minute, bpm) using a pulse oximeter. Measurements will be taken at two time points: 1. At baseline (pre-procedure, at set) 2. Immediately after local anesthesia administration
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 23 Feb 2026.
- Background: PubMed 20331333Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.
- Background: PubMed 31077857Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.
- Background: PubMed 36151976Kaya E, Yildirim S. Effect of a needle-free system versus traditional anesthesia on pain perception during palatal injections in children. Int J Paediatr Dent. 2023 Mar;33(2):132-140. doi: 10.1111/ipd.13028. Epub 2022 Oct 17.
- Background: PubMed 40247611Maganur PC, Vishwanathaiah S, Jafer MA, Moafa I, Alessa N, Assiry AA, Altowairqi SA, Basheri AAM, Najmi HH, Alhazmi ZA, Maafa SM, Jeevanandan G, Manoharan V. Pain and Anxiety Levels During Dental Restorations in Primary Molars: INJEX Needleless System vs Traditional Syringe. Med Sci Monit. 2025 Apr 18;31:e947691. doi: 10.12659/MSM.947691.
- Background: PubMed 37635474Patel M, Bhatt R, Mehta M, Patel C, Patel F, Makwani D. A comparative assessment of efficacy and preference between needleless device INJEX and insulin syringe for anesthetizing primary maxillary teeth in children aged 4-9 years: A split-mouth crossover randomized clinical study. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):149-155. doi: 10.4103/jisppd.jisppd_199_23.
- Background: PubMed 30673030Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INJEX 30 and Traditional syringe in people with This Study Aims to Evaluate the Effectiveness of the INJEX Device in Administering Local Anesthesia, run by Damascus University at 1 site in Syria.
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 3 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 23 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 1 site in Syria. 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?
Dental Pain - FLACC Scale (time frame: During local anesthesia administration, from insertion of the device into the oral cavity until completion of the anesthetic delivery and removal of the device.). The study lists 3 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 NCT07426523, which also lists 6 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 23 Feb 2026.