Pain ManagementPARONCT07299006
Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.
A study testing Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. and Non-pharmacological and standard pharmacological interventions. in people with Pain Management, run by Fondation Lenval at 5 sites in France.
Trial summary
Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are… Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. and Non-pharmacological and standard pharmacological interventions.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Mar 2026to 30 Mar 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 12 months and 7 years.
- Requirement for peripheral intravenous catheterization (PIC).
- Written informed consent obtained from at least one parent or legal guardian.
- Affiliation with the national health insurance system (social security).
Who cannot join
- Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs).
- Visual or hearing impairment.
- Known psychiatric disorder.
- Inability to understand French.
- Life-threatening emergency requiring immediate intervention.
- Need for strong analgesic medication (e.g., morphine, ketamine, or intranasal analgesics).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Chu Morvan
Brest
Elise SACAZE, MD, 04.92.22.36.57 ext. +33, elise.sacaze@chu-brest.fr
- Not yet recruiting
Centre hospitaliers de Grasse
Grasse
Blandine DESSE, MD, 04.92.09.75.41, b.desse@chu-grasse.fr
- Recruiting
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, 06000
Aline JOULIE, +33492030520, joulie.a@chu-nice.fr
Barabra LE GALLO, MD
- Recruiting
CHU de NICE
Nice
Jennifer Battista, MD, +33492030039, battista.j@chu-nice.fr
- Not yet recruiting
Centre Hospitalier Universitaire Toulouse
Toulouse, 31059
Camille Brehin, Pr, 0534558420 ext. +33, brehin.c@chu-toulouse.fr
Camille Brehin, Pr
About this study
Official title: Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children, a Multicenter Randomized Prospective Study.
Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term.
The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established.
Read more
The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture.
This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group.
Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.
- Conditions
- Pain Management
- Being tested
- Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot., Non-pharmacological and standard pharmacological interventions.
- Keywords
- pediatric
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.Device
Also called PARO group
The child will be admitted to the emergency department.
If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin 30 to 60 minutes prior to the procedure.
To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure.
If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child during the procedure.
The procedure will begin with skin disinfection and identification of a suitable vein.
For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin.
The procedure will be considered complete once the needle is withdrawn and a dressing is applied.
Non-pharmacological and standard pharmacological interventions.Other
Pharmacological interventions:
EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) EMLA cream (Eutectic Mixture of Local Anesthetics)
Non-pharmacological interventions:
Music therapy Audiovisual distraction (e.g., watching cartoons)
| Study group | Role | What they receive |
|---|---|---|
| Control group : standard multimodal stratgey | Active comparator | The child will be admitted to the emergency department.
If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin prior to the procedure.
If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, the child will inhale the gas via a mask during the procedure.
Non-pharmacological interventions, such as music therapy and/or watching cartoons, may also be used as part of standard care.
The procedure will begin with skin disinfection and identification of a suitable vein.
For the purposes of the study, the start of the procedure is defined as the moment the needle first penetrates the skin.
The procedure is considered complete once the needle is withdrawn and a dressing is applied. Receives: Other: Non-pharmacological and standard pharmacological interventions. |
| Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti | Experimental | The child will be admitted to the emergency department.
If topical anesthesia (EMLA cream) is used to reduce pain, it will be applied to the skin 30 to 60 minutes prior to the procedure.
To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure.
If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child.
The procedure will begin with skin disinfection and identification of a suitable vein.
For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin.
The procedure will be considered complete once the needle is withdrawn and a dressing is applied. Receives: Device: Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization
The effectiveness of PARO in reducing procedural pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale. The FLACC is a validated hetero-assessment tool for evaluating pain in children aged 12 months to 7 years, particularly in the context of acute postoperative pain and brief painful medical procedures.
This scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates a relaxed and comfortable child, while scores of 7 to 10 indicate severe pain or significant distress. A score of ≥3 is commonly considered indicative of clinically relevant pain requiring analgesic intervention.
Measured: periprocedural
Secondary outcomes (7)
Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization
Children's distress will be evaluated using the PRIC scale (Procedural Restraint Intensity in Children), which measures the intensity of restraint required during pediatric procedures as an indirect indicator of procedural distress. The scale is stratified into five levels, assessing both the degree of physical restraint applied and the child's behavioral response. A score ≥3 is considered clinically significant and should prompt reassessment of pain and/or anxiolytic management. The PRIC scale has been preliminarily validated in a cohort of 20 children aged 2 months to 13 years, showing acceptable metrological properties; however, further studies are ongoing to confirm its validity in real-life clinical settings, as no gold standard currently exists. Procedural distress will be assessed at two time points: during skin disinfection with identification of the puncture site, and at skin penetration. Results will be compared between groups
Measured: skin disinfection AND Skin penetration
Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization
Heart rate variability may serve as an indirect indicator of pain intensity, reflecting autonomic (sympathetic and parasympathetic) responses to nociceptive stimulation. Heart rate is a recognized physiological marker of pain in infants and children and may increase by approximately 10 to 25 beats per minute during painful procedures.
In this study, heart rate will be used to assess the effect of PARO on procedural pain. It will be continuously monitored using standard clinical monitoring equipment. Measurements will be recorded at two time points: 15 minutes before the procedure during PARO introduction (if applicable), and at the time of venipuncture. The primary analysis will focus on the change (delta) in heart rate between baseline (15 minutes before the procedure) and venipuncture. Comparisons will be made between study groups.
Measured: periprocedural
Number of attempts required for successful peripheral venous access
The effectiveness of the procedure will also be assessed by the number of attempts required to establish peripheral venous access. An attempt is defined as each skin puncture attempt. For ethical reasons, a maximum of three attempts will be permitted; beyond this threshold, the procedure will be considered a failure and alternative management in the operating room will be proposed.
Measured: During the procedure (up to 3 attempts)
Assessment of parental satisfaction
Parental satisfaction will be evaluated using a structured questionnaire administered to parents following the procedure. The instrument includes four items rated on a Likert-type response scale.
Measured: 15 minutes after the end of the procedure
Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI)
Parental anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI is a self-administered questionnaire consisting of 40 items divided into two subscales: the State Anxiety subscale (STAI Form Y-1), which assesses current anxiety levels, and the Trait Anxiety subscale (STAI Form Y-2), which assesses general predisposition to anxiety.
Each item is rated on a 4-point Likert scale, with scores ranging from 1 (low anxiety) to 4 (high anxiety).
Measured: at the end of the procedure
Failure of peripheral venous access after three attempts
Failure of peripheral intravenous catheterization is defined as the inability to establish venous access after a maximum of three attempts, as previously defined, necessitating management by the anesthesia team.
Measured: periprocedural
Assessment of paramedical staff satisfaction
Satisfaction of the paramedical team will be assessed using a dedicated questionnaire administered to all nursing staff involved in the study at the end of the trial. The questionnaire will be completed once by each participant and consists of four items rated on a Likert-type scale.
In addition, one or more debriefing meetings will be organized with the care team at study completion to gather qualitative feedback regarding their experience and perceptions of the intervention
Measured: 15 minutes after the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start3 Mar 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
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 Pain ManagementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara LE GALLO, MD, Principal investigator, Hôpitaux pédiatrique Nice CHU Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299006
- Sponsor's protocol ID
- 24-HPNCL-05 PARO
- Other IDs
- 2025-A00197-42
- Acronym
- PARO
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montaland C, Le Gallo B, Tran A, Guellec I, Dumas LE, Devos C, Joulie A, Lussiez W, Fontas E, Battista J. Multicentre randomised controlled trial evaluating PARO for pain and anxiety during peripheral intravenous cannulation in children in French paediatric emergency departments and paediatric units: study protocol. BMJ Open. 2026 Sep 25;16(9):e118505. doi: 10.1136/bmjopen-2026-118505.
PubMed 42790916
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children, a Multicenter Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT07299006
- Acronym / sponsor ID
- PARO / 24-HPNCL-05 PARO
- Conditions
- Pain Management
- Keywords
- pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term.
The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established.
The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture.
This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group.
Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group : standard multimodal stratgey | Active comparator | Other: Non-pharmacological and standard pharmacological interventions.The child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin prior to the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, the child will inhale the gas via a mask during the procedure. Non-pharmacological interventions, such as music therapy and/or watching cartoons, may also be used as part of standard care. The procedure will begin with skin disinfection and identification of a suitable vein. For the purposes of the study, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure is considered complete once the needle is withdrawn and a dressing is applied. |
| Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti | Experimental | Device: Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.The child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used to reduce pain, it will be applied to the skin 30 to 60 minutes prior to the procedure. To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child. The procedure will begin with skin disinfection and identification of a suitable vein. For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure will be considered complete once the needle is withdrawn and a dressing is applied. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 12 months and 7 years.
- Requirement for peripheral intravenous catheterization (PIC).
- Written informed consent obtained from at least one parent or legal guardian.
- Affiliation with the national health insurance system (social security).
Key exclusion criteria (6 listed)
- Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs).
- Visual or hearing impairment.
- Known psychiatric disorder.
- Inability to understand French.
- Life-threatening emergency requiring immediate intervention.
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 |
|---|---|---|
| Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.Also: PARO groupThe child will be admitted to the emergency department. If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin 30 to 60 minutes prior to the procedure. To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure. If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child during the procedure. The procedure will begin with skin disinfection and identification of a suitable vein. For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin. The procedure will be considered complete once the needle is withdrawn and a dressing is applied. | Device | Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti |
| Non-pharmacological and standard pharmacological interventions.Pharmacological interventions: EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) EMLA cream (Eutectic Mixture of Local Anesthetics) Non-pharmacological interventions: Music therapy Audiovisual distraction (e.g., watching cartoons) | Other | Control group : standard multimodal stratgey |
Primary outcome
FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization
Time frame: periprocedural
The effectiveness of PARO in reducing procedural pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale. The FLACC is a validated hetero-assessment tool for evaluating pain in children aged 12 months to 7 years, particularly in the context of acute postoperative pain and brief painful medical procedures. This scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates a relaxed and comfortable child, while scores of 7 to 10 indicate severe pain or significant distress. A score of ≥3 is commonly considered indicative of clinically relevant pain requiring analgesic intervention.
7 secondary outcomes
Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization
Time frame: skin disinfection AND Skin penetration
Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization
Time frame: periprocedural
Number of attempts required for successful peripheral venous access
Time frame: During the procedure (up to 3 attempts)
Assessment of parental satisfaction
Time frame: 15 minutes after the end of the procedure
Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI)
Time frame: at the end of the procedure
Failure of peripheral venous access after three attempts
Time frame: periprocedural
Assessment of paramedical staff satisfaction
Time frame: 15 minutes after the end of the procedure.
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 20 Aug 2026.
- Derived from this study: PubMed 42790916Montaland C, Le Gallo B, Tran A, Guellec I, Dumas LE, Devos C, Joulie A, Lussiez W, Fontas E, Battista J. Multicentre randomised controlled trial evaluating PARO for pain and anxiety during peripheral intravenous cannulation in children in French paediatric emergency departments and paediatric units: study protocol. BMJ Open. 2026 Sep 25;16(9):e118505. doi: 10.1136/bmjopen-2026-118505.
- 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.
Barbara LE GALLO, MD principal investigator
Hôpitaux pédiatrique Nice CHU Lenval
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. and Non-pharmacological and standard pharmacological interventions. in people with Pain Management, run by Fondation Lenval at 5 sites in France.
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 4 inclusion and 6 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 ALINE JOULIE, PHD (+33492030520, joulie.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization (time frame: periprocedural). 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 NCT07299006, 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 20 Aug 2026.