Total Hip Arthroplasty (THA)KINCISENCT05480813
Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty
A study testing Automated KINCISE™ impaction system versus handheld traditional mallet and Efficiency and ergonomics analysis and physical assessments in people with Total Hip Arthroplasty (THA), run by DEO NV at 1 site in Belgium.
Trial summary
This study will investigate and evaluate the ergonomic impaction and the operational efficiency of the KINCISE™ impaction system in comparison with the manual impaction of a handheld traditional mallet in total hip arthroplasty (THA) procedures. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Automated KINCISE™ impaction system versus handheld traditional mallet and Efficiency and ergonomics analysis and physical assessments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2022to 19 Jul 2022
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hip surgeon
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty: Ergonomic and Efficiency Evaluation
This study will investigate and evaluate the ergonomic impaction and the operational efficiency of the KINCISE™ impaction system in comparison with the manual impaction of a handheld traditional mallet in total hip arthroplasty (THA) procedures.
Read the detailed description
The automated impaction technology of Depuy Sythes (J\&J, Warschau), i.e. KINCISE™, can help surgeons impacting the femur in THA surgeries with constant and consistent energy. Furthermore, the bone preparation, implant positioning and implant assembly automate. Next to that, the KINCISE™ is developed to eliminate mallet impaction methods and thus can reduce the physical fatigue of the surgeon during THA procedures, leading to more reproducible and accurate femur manipulation even during the last procedure of the OR day. Two main research questions will be investigated: "Does the KINCISE™ automated impaction lead to a significant reduction in mental and physical fatigue in comparison with mallet impaction?" and "Does the KINCISE™ automated impaction lead to a reduction in OR time?".
Measurements will be executed during 4 OR days. During each OR day exclusively Kincise impaction (N=2) or handheld traditional mallet impaction (N=2) will be performed. The impaction technique will be randomised and the OR setup will be equal in both situations. The one participant in the study is an orthopaedic hip surgeon. He will execute all the THA procedures and undergo all the physical and cognitive tests. The entire study will be assessed by 2 parties of experienced assessors who are not involved in the surgical procedures: BeScored Institute and DEO.
Each OR day, 2 evaluation sessions and 1 mid break session will be held, led by BeScored Institute: in the morning from 06:50am till 08am, during the afternoon from 03:30pm till 04:40pm and during lunch breaks from 11:30am till 12:05pm. Before each morning evaluation session a cognitive task test of 5 minutes will be executed to get familiar with the cognitive tasks of the evaluation sessions. During each evaluation session the following tests will be executed in the same order: psychometric assessments (7 minutes, consisting of 'mindfulness inventory for sport' questionnaire, perfection for stress scale and observed physical fatigue), energy evaluation and stress levels (5 minutes, consisting of heart beat variability measurements, saliva cortisol levels and saliva alfa-amylase levels), cognitive tasks (30 minutes, consisting of Simon test, pattern-comparison test and psychomotor test) and physical tests (20 minutes, consisting of handgrip test, shoulder endurance, planking and isometric mid-thigh pull performance). During the mid break session only the psychometric assessments and cognitive tasks will be executed.
During the THA procedures itself, DEO will evaluate other ergonomics and operational efficiency using the validated DEO Data Collection Platform including datapoints specific to the use of automated and manual impaction, and RULA and REBA methods.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Automated KINCISE™ impaction system versus handheld traditional mallet, Efficiency and ergonomics analysis and physical assessments
- Keywords
- KINCISE™, Operational efficiency, Ergonomic impaction, Total Hip Arthroplasty (THA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated KINCISE™ impaction system versus handheld traditional malletDevice
The KINCISE™ Surgical Automated System (KINCISE) (DePuy Synthes Products, Inc, Warsaw, IN) was developed to replace the handheld mallet traditionally used in total hip arthroplasty (THA). The device is an FDA-approved medical instrument.
Efficiency and ergonomics analysis and physical assessmentsOther
Operational efficiency, ergonomic impaction, cognitive/physical/stress level evaluations,
| Study group | Role | What they receive |
|---|---|---|
| Prof. Dr. K. Corten | Other | The one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a standard mallet. He will undergo physical and cognitive test before and after the OR day and during lunch breaks. Next to that, operational efficiency and ergonomic impaction will be analysed Receives: Device: Automated KINCISE™ impaction system versus handheld traditional mallet; Other: Efficiency and ergonomics analysis and physical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive fatigue - Mindfulness Inventory for Sport
The surgeon's ability to remain mindful during the working day will be assessed via the Mindfulness Inventory for Sport, adapted for the purpose of this study. Specifically, this questionnaire involves 15 items and 3 dimensions of mindfulness: awareness, non-judgmentally, refocusing. In addition, a modified version of the Perception for Stress Scale will be used before and after. Perceived physical fatigue has also been assessed at rest using a 10-cm visual analogic scale ranging from "Not fatigued at all" to "Very fatigued". Finally, after each physical testing, the participant will be asked to provide a verbal rating of perceived exertion (RPE) using a visual Borg (6-20) scale[26]. RPE was defined as the "perceived difficulty to exert the physical effort before exhaustion".
Measured: 720 minutes
Cognitive fatigue - Simon Task
The Simon task is a selective inhibition task in which the participant is required to respond as quickly and accurately as possible to the color of a stimulus displayed on a screen regardless its spatial location. Then, depending on its left or right location, the user may be required to withdraw an automatic impulse to be able to answer according to the color of the stimulus. The participant will be asked to respond by pressing the appropriate left or right buttons according to the color of a circle delivered either to the left or to the right of the white gaze-fixation cross. The task includes two equiprobable trial types: the congruent trials during which the spatial location of the stimulus corresponded to the task-relevant aspect of the stimulus, and the incongruent trials in which the spatial location of the stimulus corresponded to the opposite spatial location of the response.
Measured: 720 minutes
Cognitive fatigue - Pattern-comparison task
A pattern-comparison task will also be carried out to assess the surgeon's ability to visually identify anomalies, equipment failures, compliance checks, etc. throughout a surgery. Specifically, in order to test the surgeon's ability to quickly determine the compatibility (similarity) and incompatibility (dissimilarity) of stimuli, a visual comparison task will be performed. The aim will be to respond via the computer keyboard to the convergent dimension of 2 images displayed on the screen for 30 trials, and then to the non-convergent dimension for another 30 trials, in a time lapse of 1.5 sec per trial.
Measured: 720 minutes
Cognitive fatigue - Psychomotor task
The effectiveness of the and surgeon's motor control will be assessed to consider whether careful manual interventions could potentially be affected by both surgical conditions (Kincise automated impaction vs handheld impaction). A psychomotor task will therefore be formed with the instruction to follow, via a computer mouse, the predictable movement of a light spot on the screen. One minute of evaluation will be carried out, with the time of contact with the light target and the average distance to this target as variables of interest.
Measured: 720 minutes
Physical fatigue -
A plank to fatigue test (PFT) will be used to assess lumbar muscle fatigue. Between experimental sessions, the same distance between the 2 feet, between the 2 elbows and between the hip and the floor, will be required for each participant. The distance between the hip and the floor shall serve as the measure of exhaustion. Exhaustion is declared when the distance between the participant's hip and the floor is reduced by more than 2 cm for more than 5 sec.
Measured: 720 minutes
Physical fatigue - Shoulder endurance
Shoulder endurance and deltoideus anterior muscle fatigue will be assessed via light weightlifting. In particular, the participant will be required to maintain a 3 kg weight in front of him, with the arms stretched out (perpendicular to the trunk, 90° adduction) and during 3 periods of 10 sec interspaced with 10-sec resting periods.
Measured: 720 minutes
Physical fatigue - Handgrip test
A handgrip test will be carried out using a hand dynamometer (microFET® Digital HandGRIP Dynamometer, USA). This shall enable us to assess the strength decline of the flexor's muscles of the participant's dominant hand. Ten repeated maximal voluntary contractions shall be performed in 20 sec (i.e., 1 contraction every 2 sec).
Measured: 720 minutes
Physical fatigue - Isometric mid-thigh pull test
an Isometric Mid-Thigh Pull Performance (IMTPP) will be used as a measure of thighs strength of endurance. The posture of this exercise is characterized by the two right angles formed by the body, one at the hips and one at the knees. The participant will also be required to keep their arms stretched out in front of them until exhaustion to avoid compensation movements.
Measured: 720 minutes
Stress - Salivary cortisol & alpha-amylase
We will observe the variations of both salivary cortisol and alpha-amylase in this study at different timepoints. On the morning of each experimental day and at the end of the surgery, the surgeon will provide a 4-mL saliva sample via passive drool. The samples will be obtained in a fasted-state at 5:00 AM and at 4:40 PM and will be promptly frozen at -80°C
Measured: 720 minutes
Operational efficiency
Efficiency will be assessed using OR time, by comparing the OR days and procedures where the KINCISE tool or the mallet is used.
A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.
Measured: 28 hours
Ergonomic impaction
Measurement of weight of Kincise and mallet, audio of impaction (Kincise vs mallet) and the surgeon's posture assessment using RULA and REBA method will be combined to report ergonomic impaction on the surgeon by DEO
Measured: 28 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start14 Jul 2022
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a traditional handheld mallet. He will undergo physical and cognitive tests before the OR day, during lunch breaks and after the OR day. Next to that, operational efficiency and ergonomic impaction will be analysed.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- DEO NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeScored Institute
- Responsible party
- Sponsor
- Investigators
- Jeroen Dille, Study director, DEO NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480813
- Sponsor's protocol ID
- KINCISE
- Acronym
- KINCISE
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty: Ergonomic and Efficiency Evaluation
- ClinicalTrials.gov ID
- NCT05480813
- Acronym / sponsor ID
- KINCISE / KINCISE
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- KINCISE™, Operational efficiency, Ergonomic impaction, Total Hip Arthroplasty (THA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- DEO NVIndustry (pharma, biotech, devices)
- Collaborators
- BeScored Institute
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 29 Jul 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.
This study will investigate and evaluate the ergonomic impaction and the operational efficiency of the KINCISE™ impaction system in comparison with the manual impaction of a handheld traditional mallet in total hip arthroplasty (THA) procedures.
Detailed description
The automated impaction technology of Depuy Sythes (J\&J, Warschau), i.e. KINCISE™, can help surgeons impacting the femur in THA surgeries with constant and consistent energy. Furthermore, the bone preparation, implant positioning and implant assembly automate. Next to that, the KINCISE™ is developed to eliminate mallet impaction methods and thus can reduce the physical fatigue of the surgeon during THA procedures, leading to more reproducible and accurate femur manipulation even during the last procedure of the OR day. Two main research questions will be investigated: "Does the KINCISE™ automated impaction lead to a significant reduction in mental and physical fatigue in comparison with mallet impaction?" and "Does the KINCISE™ automated impaction lead to a reduction in OR time?".
Measurements will be executed during 4 OR days. During each OR day exclusively Kincise impaction (N=2) or handheld traditional mallet impaction (N=2) will be performed. The impaction technique will be randomised and the OR setup will be equal in both situations. The one participant in the study is an orthopaedic hip surgeon. He will execute all the THA procedures and undergo all the physical and cognitive tests. The entire study will be assessed by 2 parties of experienced assessors who are not involved in the surgical procedures: BeScored Institute and DEO.
Each OR day, 2 evaluation sessions and 1 mid break session will be held, led by BeScored Institute: in the morning from 06:50am till 08am, during the afternoon from 03:30pm till 04:40pm and during lunch breaks from 11:30am till 12:05pm. Before each morning evaluation session a cognitive task test of 5 minutes will be executed to get familiar with the cognitive tasks of the evaluation sessions. During each evaluation session the following tests will be executed in the same order: psychometric assessments (7 minutes, consisting of 'mindfulness inventory for sport' questionnaire, perfection for stress scale and observed physical fatigue), energy evaluation and stress levels (5 minutes, consisting of heart beat variability measurements, saliva cortisol levels and saliva alfa-amylase levels), cognitive tasks (30 minutes, consisting of Simon test, pattern-comparison test and psychomotor test) and physical tests (20 minutes, consisting of handgrip test, shoulder endurance, planking and isometric mid-thigh pull performance). During the mid break session only the psychometric assessments and cognitive tasks will be executed.
During the THA procedures itself, DEO will evaluate other ergonomics and operational efficiency using the validated DEO Data Collection Platform including datapoints specific to the use of automated and manual impaction, and RULA and REBA methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a traditional handheld mallet. He will undergo physical and cognitive tests before the OR day, during lunch breaks and after the OR day. Next to that, operational efficiency and ergonomic impaction will be analysed.
| Arm | Type | Receives |
|---|---|---|
| Prof. Dr. K. Corten | Other | Device: Automated KINCISE™ impaction system versus handheld traditional mallet, Other: Efficiency and ergonomics analysis and physical assessmentsThe one participant of the study is an orthopaedic surgeon. He will execute 48 THA procedures during 4 study days. 24 THA procedures will be executed using the automated KINCISE™ impaction system and 24 THA procedures will be executed using a standard mallet. He will undergo physical and cognitive test before and after the OR day and during lunch breaks. Next to that, operational efficiency and ergonomic impaction will be analysed |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hip surgeon
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Automated KINCISE™ impaction system versus handheld traditional malletThe KINCISE™ Surgical Automated System (KINCISE) (DePuy Synthes Products, Inc, Warsaw, IN) was developed to replace the handheld mallet traditionally used in total hip arthroplasty (THA). The device is an FDA-approved medical instrument. | Device | Prof. Dr. K. Corten |
| Efficiency and ergonomics analysis and physical assessmentsOperational efficiency, ergonomic impaction, cognitive/physical/stress level evaluations, | Other | Prof. Dr. K. Corten |
Primary outcome
Cognitive fatigue - Mindfulness Inventory for Sport
Time frame: 720 minutes
The surgeon's ability to remain mindful during the working day will be assessed via the Mindfulness Inventory for Sport, adapted for the purpose of this study. Specifically, this questionnaire involves 15 items and 3 dimensions of mindfulness: awareness, non-judgmentally, refocusing. In addition, a modified version of the Perception for Stress Scale will be used before and after. Perceived physical fatigue has also been assessed at rest using a 10-cm visual analogic scale ranging from "Not fatigued at all" to "Very fatigued". Finally, after each physical testing, the participant will be asked to provide a verbal rating of perceived exertion (RPE) using a visual Borg (6-20) scale[26]. RPE was defined as the "perceived difficulty to exert the physical effort before exhaustion".
Cognitive fatigue - Simon Task
Time frame: 720 minutes
The Simon task is a selective inhibition task in which the participant is required to respond as quickly and accurately as possible to the color of a stimulus displayed on a screen regardless its spatial location. Then, depending on its left or right location, the user may be required to withdraw an automatic impulse to be able to answer according to the color of the stimulus. The participant will be asked to respond by pressing the appropriate left or right buttons according to the color of a circle delivered either to the left or to the right of the white gaze-fixation cross. The task includes two equiprobable trial types: the congruent trials during which the spatial location of the stimulus corresponded to the task-relevant aspect of the stimulus, and the incongruent trials in which the spatial location of the stimulus corresponded to the opposite spatial location of the response.
Cognitive fatigue - Pattern-comparison task
Time frame: 720 minutes
A pattern-comparison task will also be carried out to assess the surgeon's ability to visually identify anomalies, equipment failures, compliance checks, etc. throughout a surgery. Specifically, in order to test the surgeon's ability to quickly determine the compatibility (similarity) and incompatibility (dissimilarity) of stimuli, a visual comparison task will be performed. The aim will be to respond via the computer keyboard to the convergent dimension of 2 images displayed on the screen for 30 trials, and then to the non-convergent dimension for another 30 trials, in a time lapse of 1.5 sec per trial.
Cognitive fatigue - Psychomotor task
Time frame: 720 minutes
The effectiveness of the and surgeon's motor control will be assessed to consider whether careful manual interventions could potentially be affected by both surgical conditions (Kincise automated impaction vs handheld impaction). A psychomotor task will therefore be formed with the instruction to follow, via a computer mouse, the predictable movement of a light spot on the screen. One minute of evaluation will be carried out, with the time of contact with the light target and the average distance to this target as variables of interest.
Physical fatigue -
Time frame: 720 minutes
A plank to fatigue test (PFT) will be used to assess lumbar muscle fatigue. Between experimental sessions, the same distance between the 2 feet, between the 2 elbows and between the hip and the floor, will be required for each participant. The distance between the hip and the floor shall serve as the measure of exhaustion. Exhaustion is declared when the distance between the participant's hip and the floor is reduced by more than 2 cm for more than 5 sec.
Physical fatigue - Shoulder endurance
Time frame: 720 minutes
Shoulder endurance and deltoideus anterior muscle fatigue will be assessed via light weightlifting. In particular, the participant will be required to maintain a 3 kg weight in front of him, with the arms stretched out (perpendicular to the trunk, 90° adduction) and during 3 periods of 10 sec interspaced with 10-sec resting periods.
Physical fatigue - Handgrip test
Time frame: 720 minutes
A handgrip test will be carried out using a hand dynamometer (microFET® Digital HandGRIP Dynamometer, USA). This shall enable us to assess the strength decline of the flexor's muscles of the participant's dominant hand. Ten repeated maximal voluntary contractions shall be performed in 20 sec (i.e., 1 contraction every 2 sec).
Physical fatigue - Isometric mid-thigh pull test
Time frame: 720 minutes
an Isometric Mid-Thigh Pull Performance (IMTPP) will be used as a measure of thighs strength of endurance. The posture of this exercise is characterized by the two right angles formed by the body, one at the hips and one at the knees. The participant will also be required to keep their arms stretched out in front of them until exhaustion to avoid compensation movements.
Stress - Salivary cortisol & alpha-amylase
Time frame: 720 minutes
We will observe the variations of both salivary cortisol and alpha-amylase in this study at different timepoints. On the morning of each experimental day and at the end of the surgery, the surgeon will provide a 4-mL saliva sample via passive drool. The samples will be obtained in a fasted-state at 5:00 AM and at 4:40 PM and will be promptly frozen at -80°C
Operational efficiency
Time frame: 28 hours
Efficiency will be assessed using OR time, by comparing the OR days and procedures where the KINCISE tool or the mallet is used. A granular analysis from the timestamps will be conducted using standard descriptive statistics. Additionally, the impaction process will be further analyzed, broken down into parts.
Ergonomic impaction
Time frame: 28 hours
Measurement of weight of Kincise and mallet, audio of impaction (Kincise vs mallet) and the surgeon's posture assessment using RULA and REBA method will be combined to report ergonomic impaction on the surgeon by DEO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- 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. This study is not recruiting at the moment.
Jeroen Dille study director
DEO NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated KINCISE™ impaction system versus handheld traditional mallet and Efficiency and ergonomics analysis and physical assessments in people with Total Hip Arthroplasty (THA), run by DEO NV at 1 site in Belgium.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. 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 Belgium. 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?
Cognitive fatigue - Mindfulness Inventory for Sport (time frame: 720 minutes). The study lists 11 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 29 Jul 2022.